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Title: Hyperbaric Therapy-Based Multimode Therapy for children  with Cerebral Palsy  

Author: Dr. Arun Mukherjee, MD  

Director, UDAAN for the Differently Abled,

A-59 Kailash Colony, New Delhi, India

INTRODUCTION  

Cerebral Palsy (CP):  

Abnormalities of tone are an integral component of many chronic motor disorders of  childhood. These disorders result from dysgenesis or injury to developing motor pathways in  the cortex, basal ganglia, thalamus, cerebellum, brainstem, central white matter or spinal  cord. The major damage is to the developing fetal / neonatal brain, mostly affecting the  poorly vascularized Internal Capsule, Descending Cerebro- and Cerebello- Spinal tracts, thus  affecting various motor functions. When the injury occurs in children before 2 years of age,  the term Cerebral Palsy (CP) is often used.

Management of CP  

The classical management of CP is Standard Therapy comprising individualised, need based  and target-oriented Physiotherapy, Occupational therapy, Special Education and Speech  Therapy. These are often offered as exotic management techniques such as Peto technique,  NDT (Neuro-Developmental Therapy), Bobbath technique, etc. Down at heart, they are all  specialised forms of Standard Therapy to derive the best physical and psychosocial outcomes  within the possibilities of neural function left after the original brain injury.  Hoping that these standard therapies alone can solve the problems of the CP child is like  hoping that changing the tyres and lubricating the wheels and axles of a car will make it run  better when its engine is choked with carbon deposits. We need to repair the engine if the  fault is in the engine: it is as simple as that.

There are dozens of papers in world literature, unfortunately not indexed in “Free Internet  Medline” but in other more than 100 “*Lines” in the US National Library of Congress, that  are available only on payment per article, and hence rarely sought out. They carry many  reports on CP children treated with Hyperbaric Oxygen Therapy, showing improvement and  increase in serial GMFM scores over time that were five to ten times faster than that achieved  in the best centres of standard therapies.

UDAAN for the Disabled  

UDAAN for the Disabled is a non-profit organization, recognized and partially aided by the  Government of India. We are offering standard therapies since 1994 to children affected by  various forms of Neurodevelopmental disabilities, in which CP predominates. Since 2001, we  started a research project to study the benefits of HBOT-based multimode therapy of CP. We  have a control batch of CP children that did not receive HBOT, as well as batches that  received HBOT in a Multiplace rigid chamber either at 1.75 ATA (till July 2004) or 1.5 ATA  (after July 2004) with 100% oxygen delivered by an Amron mask. There is a fourth batch  that received mild pressurized air (with no additional oxygen supplementation either with a  Concentrator or oxygen cylinder) at 1.3 ATA using the largest size OxyHealth soft portable  chamber (since 2006).

The study is a prospective open non-randomised study, with batches decided by the parent  based on their own convenience and financial status. It is an ongoing study. Hence, our  database is growing by the year. This article represents data as available till June 2008.

Evolution of existing HBOT based Multimode Therapy for CP in India  June 2001

UDAAN pioneered in India the study of 1.75 HBOT at 100% O2 as supplement to Standard  Therapy (OT + PT + Special Education + Speech Therapy) for CP children.  March 2003

The first UDAAN paper on the use of HBOT in CP (Control 15 vs Test 15) was presented at  the Annual Conference of Indian occupational Therapy Assoc. at Bangalore (Amit Sethi and  Arun Mukherjee) and won the best scientific paper award. This was later reported in  July 2003

3rd Int. Symposium on HBOT & the Brain Damaged Child (Florida): Presented interim data  on 20 CP children given only Standard Therapy vs. 20 matching Test group of 20 CP  Children given additional HBOT (40 sessions of 1.75 ATA with 100% O2). Trend favored  the HBOT group on all parameters.

July 2004

4th Int. Symp. on HBOT …. (Florida): Presented data on 39 CP children given 40 sessions of  HBOT at 1.75 ATA, with statistically significant improvement over the batch given only  Standard Therapy (n=20) .

Dr. Paul Harch advised us to shift down to 1.5 ATA for better results. We did as advised.  July 2006

5th Int. Symp. on HBOT …. (Florida): Presented ongoing long term (6 to 8 months) study  data of 84 CP children given supplemental HBOT (sub-group analysis of 1.5 & 1.75 ATA not  done) Vs. 20 on Standard Therapy alone.

Data on interim pilot study on 7 given 1.3 ATA Hyperbaric Air also shown but not included  in analysis.  

July 2008

6th Int. Symp. on HBOT …. (Torrance CA): Presented data on 128 CP children who  completed at least six months of follow up, after receiving only Standard Therapies (n=20),  or standard therapies supplemented by (a) regular 100% O2 HBOT at 1.75 ATA (n=60), (b)  regular 100% O2 HBOT at 1.5 ATA (n=24), or (c) HB-Air at 1.3 ATA using room air only  (n=24).

Materials and Methods  

Selection Criteria  

Inclusion Criteria  

  • All types of CP in children aged mostly between 1 to 5 years, oldest up to Teen age  • Either Sex
  • Any I.Q. level
  • Pre-HBOT SPECT Scan showing presence of recoverable penumbra in test subjects.  • Those living in Delhi or willing to live in Delhi for 6 – 8 months within reasonable  distance of UDAAN to facilitate daily transportation

Exclusion Criteria  

  • Uncontrolled Epilepsy
  • Uncontrolled Bronchospastic and/or E.N.T. disorders.
  • Any Genetic Disorders
  • Pervasive Developmental Disorders.

Grouping  

Every child received matching Standard Therapy at the same venue by the same group of  therapists, using the same protocol, same equipment, and the same duration of 6 to 8 months. 

  • Batch – A: No hyperbaric therapy
  • Batch – B: 40 sessions of 1.75 ATA HBOT with 100% Oxygen during 1st two months  • Batch – C: 40 sessions of 1.50 ATA HBOT with 100% Oxygen during 1st two months  • Batch – D: 40 sessions of 1.30 ATA HBAT with room air during 1st two months
  1. The Hyperbaric groups also received CP Specific Acupuncture one session a day for 60  sessions as part of multimode therapy, added from 5th month onwards, after giving  HBOT / HBA enough time to exert its effects.
  2. Assessments done every 2 months
  3. Data analyzed for Percentage Change from Basal to 4 and 6 Months.  Physical Assessment  
  • Standard Scales like GMFM scale are always used. We also use other relevant scales  where needed, like Modified Ashworth, BERI VMI, etc. The analytical data is based  on the GMFM Scale.
  • GMFM Measurements: Baseline, 4 months & 6 months, and now-a-days, 8 months  • Statistical evaluation: By a Bio-statistician trained at the prestigious All India Institute  of Medical Sciences, Delhi

Statistical Methods used by our Statistician  

  • Chi Squared Test for Categorical Data
  • Non Parametric Wilcoxon Mann Whitney Test for 2 Groups
  • Non Parametric Krusckal Wallis Test for more than 2 Groups
  • Non Parametric Wilcoxon Signed Rank Test for two different time periods

Assessments other than Physical  

Special Educational and Speech Therapist’s assessments are always a problem in CP due to  combination of intellectual disability & physical impairment in the children.  Hence, based on our long experience with various scales, we developed a modified scale of  22 objective parameters for cognitive changes (Special Education)

Evolved from standard scales like Vineland, Help Check list; RUTTH GRIFFITH; REEL;  FAB & BASIC MR. Each parameter has been divided into 5 achievable grades of  improvement. These grading have been customized to measure smaller differences in  Cognitive skills at 2 month intervals.

UDAAN Study Timeline  

Protocol – Standard Therapy

6 days/week, one-to-one basis, ½ Hr each daily of

  1. Physiotherapy
  2. Occupational Therapy
  3. Special Education
  4. Speech Therapy

Assessment of fitness for Hyperbaric Therapy  

Pre-HBOT SPECT Scan was done in just about every child to show ischemic brain lesion.  Each child had to undergo medical fitness by a pediatrician and an ENT specialist to ensure  safety at hyperbaric conditions. Neurological opinion was sought in children with fits, and  where needed, dose of anti-epileptic therapy was slightly increased during the HBOT phase  to minimize risk of fit relapse.

Protocol Hyperbaric Oxygen Therapy Regimen  

HBOT was done in a multiplace chamber using 15 minutes to pressurize, 15 minutes to  depressurize, and 60 minutes at pressure with 100% Oxygen given through an Amron mask.

The children received one session of HBOT a day x 40 sessions during 1st two months. The  pressure used was 1.75 ATA from 2001 to July 2004, which was subsequently reduced to 1.5  ATA as per guidance received from our mentor, Dr. Paul Harch.

Hyperbaric Air Therapy Regimen  

HBAT was done in a non-ASME-PVHO compliant OxyHealth soft chamber (their largest  chamber size used) as part of our research protocol, at 1.3 ATA using non-enriched room air,  in a dedicated air-conditioned room with filtered air. This batch duplicates the batch wrongly  and repeatedly referred to as “Placebo” by Collet, the lead author of the landmark Canadian  study of HBOT in CP (Collet, J.P., Vanasse, M., Marois, P., Amar, M., Goldberg, J., Lambert, J. et  al. (2001) Hyperbaric oxygen for children with cerebral palsy: A randomized multicentre trial. The  Lancet, 357, 582-586). Each child received one session a day x 40 days during first 2 months.

Protocol of Acupuncture  

One 45-minute session a day for 60 working days, from 5th month onwards, after benefits of  HBOT were observed. A trained qualified Acupuncture Therapist offers it. All usual aseptic  and antiseptic techniques are followed, and no complications have occurred since 2001. We  also use Laser Acupuncture where needed. The therapy is always done in close consultation  with our Occupational Therapy Dept, with reference to case-to-case physical disabilities.

Observations  

Age Group Cross tabulation  

GROUP  MIN MAX  RANGE  MEAN  Age  S.D.  MEDIAN  SE OF  

MEAN 

Control 20 1.0 17.0 16.0 3.5 3.49 3.00 0.78
1.3 24 1.5 9.0 7.5 4.87 2.16 5.00 0.44
1.5 24 1.0 13.0 12.0 4.33 3.14 3.0 0.64
1.75 60 1.0 12.0 11.0 4.22 2.47 4.0 0.24

 

Non-Parametric Kruskal-Wallis Test: p > 0.06 (NS)

Age Range Cross tabulation  

GROUP  <=2 YR  3-4 YR  5-6 YR  7-8 YR  >8 YR  TOTAL 
Control 8 (40) 9 (45) 2 (10) 0 (0) 1 (5) 20
1.3 4 (16.7) 5 (20.8) 10 (41.7) 3 (12.5) 2 (8.3) 24
1.5 7 (29.2) 9 (37.5) 3 (12.5) 2 (8.3) 3 (12.5) 24
1.75 15 (25) 24 (40) 12 (20) 6 (10) 3 (5) 60

 

Pearson Chi-Square test: p > 0.02 (NS)

Sex Division Cross tabulation  

GROUP  FEMALE  MALE  TOTAL 
Control 7 (35%) 13 (65%) 20
1.3 5 (20.8%) 19 (79.2%) 24
1.5 5 (20.8%) 19 (79.2%) 24
1.75 18 (30%) 42 (70%) 60

 

Pearson Chi-Square test p > 0.2 (NS)

Conclusion: no significant difference in Age or Sex distribution across the four  groups

Motor Changes, from baseline to 4 & 6 months in GMFM Scores  

GROUP  % CHANGE 0 – 4 MT  

MIN & MAX.  

MEAN + SD  

P = 

% CHANGE 0 TO 6 MT  

MIN & MAX.  

MEAN + SD  

P = 

Control

n=20

Min: 1.3; Max 29.9

Mean: 5.99 + 7.6

p < 0.001

Min: 2.5; Max: 59.9

Mean: 11.95 + 15.2

p < 0.001

1.3

n=24

Min:0.0; Max: 164.1

Mean: 19.41 + 34.1

p < 001

Min: 2.53 Max: 281.5

Mean: 37.3 + 58.5

P < 0.001

1.5

n=24

Min: 2.44;Max: 194.1

Mean: 22.7 + 33.5

p < 0.001

Min: 4.41; Max: 358.5

Mean 39.1 + 62.9

p < 0.001

1.75

n=60

Min: 0.58; Max: 59.1

Mean 18.3 + 14.9

p < 0.001

Min: 1.53; Max: 118.5

Mean: 37.1 + 30.0

p < 0.001

1.5+1.75 Min: 0.58; Max: 194.2

Mean 19.9 + 23.3

p < 0.001

Min: 1.53; Max: 358.5

Mean: 37.8 + 30.0

p < 0.001

 

Non Parametric Test

Wilcoxon Signed Ranks Test

Conclusion: All four groups improved statistically significantly within their own groups.  Comparative GMFM changes  

P VALUE OF % CHANGE IN GMFM  FROM BASELINE TO:  4 MT  6 MT 
1.3 vs. Control p < 0.001

HS

p < 0.005

HS

1.5 vs. Control p < 0.001

HS

p < 0.001

HS

1.75 vs. Control p < 0.001

HS

p < 0.001

HS

 

All three Hyperbaric Groups were significantly superior to Control Group.  Absolute Value Changes in GMFM Scores 

Group 0 mt

Min & Max.

Mean + SD

4 mt

Min & Max.

Mean + SD

6 mt

Min & Max

Mean + SD

Control

n=24

Min:12.1; Max: 53.6  Mean: 29.6 + 13.0 Min: 12.5; Max: 54.3  Mean: 31.0 + 12.8 Min: 12.9; Max: 55.0  Mean: 32.4 + 12.3
1.3

n=24

Min:6.8; Max: 65.5  Mean: 31.2 + 14.7 Min: 20.5; Max: 69.4  Mean: 36.7 + 13.2 Min: 24.0; Max: 71.8  Mean: 38.3 + 13.1
1.5

n=24

Min: 4.12; Max: 70.8  Mean: 34.7 + 15.4 Min: 12.1; Max: 81.9   Mean 39.6 + 15.2 Min: 18.9; Max: 86.5  Mean: 42.8 + 15.2
1.75

n=60

Min: 13.5; Max: 81.5  Mean 32.6 + 11.7 Min: 17.4; Max: 63.7  Mean: 37.3 + 10.7 Min: 21.3; Max: 69.2  Mean: 42.10+ 10.3
1.5 +1.75 Min: 4.12; Max: 70.8  Mean 33.3 + 13.1 Min: 12.1; Max: 81.9  Mean: 38.1 + 12.5 Min: 18.9; Max: 86.5  Mean: 42.3 + 12.2

 

Using these values, the efficacy of 1.3 ATA HBA was compared to the two regular 100%  oxygen based HBOT groups.

The comparative results were as follows, using Non-parametric Mann-Whitney Test:

1.3 ATA HBA vs. 1.5 HBOT:  

 At 4 months, difference not significant (p = 0.467)

At 6 months, difference not significant (p = 0.316)

1.3 ATA HBA vs. 1.75 HBOT  

 At 4 months, difference not significant (p = 0.601)

At 6 months, difference not significant (p = 0.99)

1.3 ATA HBA vs. 1.5 + 1.75 ATA HBOT  

 At 4 months, difference not significant (p = 0.509)

At 6 months, difference not significant (p = 0.126)

COGNITIVE CHANGES  

Special Education Cognitive tests by Absolute values  

Group 0 mt

Min & Max.

Mean + SD

4 mt

Min & Max.

Mean + SD

6 mt

Min & Max.

Mean + SD

Control

n=24

Min: 27; Max: 122

Mean: 48.6 + 27.4

Min: 27; Max: 122  Mean 58.5 + 28.4 Min: 27; Max: 125  Mean: 63.1 + 30.5
1.3

n=24

Min: 23; Max: 81

Mean: 38.4 + 15.4

Min: 29; Max: 88  Mean: 60.9 + 18.6 Min: 32; Max: 96  Mean: 67.4+ 21.7
1.5

n=24

Min: 26; Max: 124

Mean: 48.5 + 28.7

Min: 29 Max: 127  Mean 62.9 + 30.8 Min: 30; Max: 128  Mean: 67.6 + 30.7
1.75

n=60

Min: 26; Max: 128

Mean 48.0 + 28.1

Min: 29; Max: 130  Mean: 67.9 + 32.1 Min: 30 Max: 130  Mean: 75.1+ 33.3
1.5+1.75 Min: 26; Max: 128

Mean 48.1 + 28.1

Min: 29; Max: 130  Mean: 66.4 + 31.6 Min: 30; Max: 130  Mean: 73.1 + 32.6

 

Based on these values, we tested the changes in the two Hyperbaric Oxygen Therapy groups  as compared to changes in the 1.3 ATA Hyperbaric Air group

The comparative results were as follows, using Non-parametric Mann-Whitney Test:

1.5 ATA HBOT group 

1.5 ATA HBOT group was not statistically superior to the 1.3 ATA HBA group, with p >  0.7 at 4 months and p > 0.7 at 6 months.

1.75 ATA HBOT group 

1.75 ATA HBOT group was not statistically superior to the 1.3 ATA HBA group, with p >  0.7 at 4 months and p > 0.4 at 6 months.

1.5 + 1.75 ATA HBOT group 

The combined 1.5 ATA + 1.75 ATA HBOT group was not statistically superior to the 1.3  ATA HBA group, with p > 0.8 at 4 months and p > 0.6 at 6 months.

Cognitive Percentage Improvement  

Group % Change 0 – 4 mt

Min & Max.

Mean + SD

% Change 0 – 6 Mt

Min & Max.

Mean + SD

Control

(n-=20)

Min:0.0; Max: 121.9

Mean: 24.4 + 29.7

Min: 0.0; Max: 165.56

Mean: 34.9 + 41.6

1.3

(n=24)

Min:4.9; Max: 157.1

Mean: 65.8 + 40.4

Min: 11.1; Max: 185.7

Mean: 83.6 + 48.2

1.5

(n=24)

Min:0.0 Max: 69.3.8

Mean: 34.7 + 20.2

Min: 0.0; Max: 96.6

Mean 47.2 + 26.5

1.75

(n=60)

Min: 0.78 Max: 167.7

Mean 49.8 + 42,.3

Min: 1.56; Max: 219.35

Mean: 69.5 + 55.7

1.5+1.75

(n=84)

Min: 0.0; Max: 167,7

Mean 45.6 + 37.9

Min: 0.0; Max: 219.4

Mean: 63.3 + 50.1

 

Using these values, the three Hyperbaric groups were compared to the Control groups.  The comparative results were as follows, using Non-parametric Mann-Whitney Test:

1.3 ATA HBA group 

1.3 ATA HBA group was statistically superior to the Control, with p < 0.001 at 0 to 4  months, and p < 0.001 at 0 to 6 months.

1.5 ATA HBOT group 

1.5 ATA HBOT group was statistically superior to the Control, with p < 0.05 at 0 to 4  months, and p < 0.05 at 0 to 6 months.

1.75 ATA HBOT group 

1.75 ATA HBOT group was statistically superior to the Control, with p < 0.005 at 0 to 4  months, and p < 0.005 at 0 to 6 months.

DISCUSSION  

Efficacy  

All FOUR Groups showed significant improvement with the therapy received at UDAAN.  However, all three hyperbaric groups were significantly superior to the Control group at both  4 and 6-month follow up.

GMAE Trends  

There was a statistically significant improvement recorded by all three hyperbaric groups as  compared to the control group. No significant difference between the three Hyperbaric  Groups. We may need a much bigger database than 128 CP children to see a significant  difference. We are working towards it with our ongoing study.

The change in GMFM absolute scores after 6 months of therapy was 0.67 in Control, 1.18 at  1.3 ATA, 1.35 at 1.5 ATA and 1.6 at 1.75 ATA. These results are similar to the Lancet study  and show that hyperbaric therapy doubles the improvement rate improvement compared to  non-Hyperbaric therapy regimens, with no significant difference between the individual  hyperbaric regimens used.

Cognitive Trends 

The Cognitive tests done by the Special educators, using our own modified scale based on  available internationally recognized scales adapted to measure smaller changes in Cognitive

improvements, showed no significant difference between the three Hyperbaric Groups. We  may need a still bigger database to come to see a significant difference.

Why the non-significance between HBAT & HBOT  

Let us study with an open mind

Tissue Oxygenation  

The regular HBOT chambers rely on pure oxygen source (oxygen cylinders or piped hospital  supply). They have independent air-cooling mechanisms to maintain a comfortable  temperature inside during the procedure.

Normal tissue fluid Oxygen saturation = 0.3%. Regular HBOT, using a rigid chamber, at 1.5  to 1.75 ATA, with 60 minutes at 100% pure Oxygen, achieves tissue fluid Oxygen saturation  of about 2 to 3 ml /100 ml, representing a 7 to 10 fold rise, or, almost a 700% rise. However,

the use of a hood based close circuit also ensures that there is no inhalation of Carbon  Dioxide. Hence, its level in tissue fluid and blood remains very low.

Carbon dioxide is the most potent stimulator of respiratory effort, besides causing  vasodilatation to ensure normal tissue perfusion, which influences many neuro-endocrine and  other mechanisms in the brain and body.

Thus, a typical HBOT chamber ensures tissue and blood oxygen concentration extremely  higher than physiological levels, combined with intense vasoconstriction induced by highly  unbalanced oxygen (vasoconstrictor) to carbon dioxide (vasodilator) ratio in blood and tissue  fluid.

The low-pressure (1.3 ATA) OxyHealth Soft Hyperbaric chamber used by us compresses  normal room air to 1.3 ATA, to achieve a tissue fluid Oxygen saturation of approximately 0.4  – 0.5 ml /100 ml, or 1/3 rd to ½ fold rise = 33 to 50 % increase. This is achieved by  compressing normal room air that does not have any imbalance in its oxygen to carbon  dioxide ratio, which is what our physiology is used to, in order to maintain physiological  blood vessel patency and other neuro-hormonal regulatory balances within our systems.  Is a 33% rise in tissue Oxygen level enough?

How physiologically significant is a 33% change in our internal milieu of tissue oxygenation  as produced by 1.3 ATA Hyperbaric therapy?

  • Presume that a patient has fever with temperature of 105º F. We use an acetaminophene  (paracetamol) tablet to lower temperature by only 6%. The temperature is now normal.  • A patient develops high diastolic BP of 105 mm Hg. We use an appropriate anti hypertensive drug to lower blood pressure by only 30%. The BP is now normal.  • A patient develops acute respiratory or metabolic derangement, which acidifies his blood  and decrease blood pH to 7.0. We use appropriate IV Fluids, Nutrition and Drugs to  increase the blood pH by 6 %, which brings his blood pH back to about 7.4 or normalNOW, how significant is a 33% change in our internal milieu?  

How could HBAT be non-significantly, though marginally, superior to  regular HBOT on Cognitive parameters?  

Compressed air heats up. While it is no problem in cold climates, it is a big problem in  climate-wise hot countries like India.

When we started using such a low-pressure soft chamber in 2006, besides the additional  problem of keeping the piped air dust free to ensure no problem to the already-weak special  need child as well as prolong the life of the high-efficiency air filters attached to the air  compressors, the high heat developed inside the chamber was intolerable.  We solved this problem by centrally air-conditioning the building to 25º C, and constructing  an enclosed small cabin inside the complex with its own additional air-conditioner that

further cleaned and cooled down the cabin to 16º C. This achieved a physiologically  balanced, clean and comfortable temperature atmosphere inside the soft chamber.  However, we are now realizing that having a centrally closed air-conditioned building does  lead to some degree of carbon-dioxide recirculation. In addition, the further enclosed cabin,  which contains the chamber as well as its compressor, causes a slightly greater carbon dioxide recirculation.

What is the effect of this slightly higher carbon dioxide level on brain physiology?  We were a little surprised to see that though both motor and cognitive changes were  statistically equivalent in all three Hyperbaric groups, there was a statistically non-significant  trend in favor of regular HBOT over low pressure HBAT as far as motor (GMFM) changes  were concerned, whereas in contrast, there was a non-significant trend in favor of low  pressure HBAT as far as cognitive changes are concerned.

In his presentation at the 6th International Symposium on Hyperbaric  Oxygenation and the Future of Healing, July 24 to 26, 2008, Torrance,  California, USA, (www.hbot2008.com) Dr Julian Whitaker, M.D., (IMPROVING  HBOT OUTCOMES BY NORMALIZING C02 LEVELS) suggested that a growing body  of research suggests that breathing 100% O2 at room pressure has adverse  effects and that increasing carbon dioxide (CO2) levels obviates these  effects. Hyperoxia-induced hypocapnia narrows the blood vessels and  reduces blood flow to the brain. It activates regions of the brain that  control autonomic functions and floods the body with potentially harmful  hormones and neurotransmitters.

Studies reveal that the addition of CO2 to the gas mixture greatly  diminishes these responses and could reduce adverse effects of 100% O2.  Standard practice of 100% O2 ventilation needs to be revisited and  methods for reducing hypocapnia explored-both at room pressure and  HBOT. These include modifications to gas mixtures, breathing and  rebreathing devices, and breath holding techniques.

This is what we inadvertently achieved in our enclosed HBAT cabin. The slightly higher  CO2 levels inside the HBAT soft chambers were altering physiology in ways that need  further study, since motor controls are relatively simple brain functions whereas cognitive  and psycho-social behavior are very complex multi-region based neural functions, that are  regulated by a whole host of neuro-endocrine systems, that could be affected by changes in  vascular supply even though they may lie in non-ischemic zones. We must also remember  that the Human Body Physiology works within quite narrow physiological margins, and,  during ill health, nature usually requires only mild to moderate changes in internal  milieu to change the prognosis in favor of the patient.  

What this means  

Based on our experience, we believe 1.5 or 1.75 ATA HBOT with 100% O2 is slightly  though Non-Significantly better than 1.3 ATA HB-AIR as regards motor recovery in children  with cerebral palsy while 1.3 ATA HBAT with room air is slightly though Non-statistically  superior to regular 100% oxygen based HBOT for improving cognitive and psycho-social  abilities. Overall, they balance out in improving the prognosis of the child significantly as  compared to children receiving only standard therapy.

1.3 ATA HB-Air is statistically Non-Inferior to 1.5 or 1.75 ATA HBOT with 100% oxygen  though it costs roughly half to provide.

Possibly, more experience with CT-SPECT Fusion Scans could in future show the way as to  which regimen will possibly do cost-effectively better in which brain SPECT Scan pattern,  involving cognitive/temporal lobes or the motor areas of cerebral cortex and internal capsule.

Tolerance  

Our experience on tolerance is based on a database of 84 CP children given a minimum of 40  sessions of HBOT at 100% Oxygen and 24 matching CP children treated with a minimum of  40 sessions of 1.3 ATA HBAT using room air, compared to 20 matching CP children  (Control) who received the same Standard Therapy but no Hyperbaric Therapy in any form.  • A few children with recent history of fits had relapse of epilepsy, but its incidence was

similar to the rate of fits in Control children. We stopped therapy for 7 to 10 days, and  could complete the course in all except one child, in the 1.5 ATA group.  • His/her own mother or relation usually accompanies the CP child inside the chamber. No  case of claustrophobia was seen in the children (perhaps due to their cognitive  impairment), though some mothers or relations did have some such problem. Our Nurse  on duty accompanied their children inside the chamber in such cases.

  • There were no significant behavioral problems inside chamber, including some children  with autism, who were not a part of this particular project.
  • We have been doing HBOT since 2001 and HBAT since 2006. During this period, no  deterioration was noticed in any child treated so far.

Chamber problems  

Regular Monoplace HBOT chambers pressurize with 100% oxygen. If they start using room  air to give less costly 1.3 ATA HBAT, the condensing moisture could play havoc with the  inside chamber materials and sealing which were designed to use dry pure oxygen from a  dedicated oxygen source.

The Multiplace chambers simultaneously treat many types of patients, and not just CP.  Different indications require different pressures, often exceeding 1.5 ATA. Hence providing  the less costly 1.3 ATA in such chambers is not cost effective or feasible  Both types of regular HBOT provide 100% pure dry oxygen to the patient. Thus the patient  does not receive physiologically necessary levels of carbon dioxide. Problems associated with  carbon dioxide levels need to be studied in future. There may also be respiratory problems  later on in children receiving dry air for 1.5 hours.

The 1.3 ATA soft HBAT chambers on the other hand, provide the physiological levels of  oxygen and carbon dioxide mixture, and may be better at maintaining intracranial neuro hormonal controls. However, they supply humid air, at least in our setting, which condenses  inside the chambe. The chamber needs to be wiped clean after each round, and aerated  periodically in-between sessions.

Our suggestions for soft chambers:

  1. We normally have a tidal breath volume of 500 ml, and breathe up to about 20 times  per minute. Hence, the chamber must have a flow rate of 10 liters per minute per  person, to ensure normal oxygen supply. Since the chamber normally has a child and  a relation, rarely the nurse also, we need a minimum flow rate of 30 liters/minute.  The Oxyhealth chamber we use has a flow rate of 50 liters/minute.
  2. There should be a dehumidifier inline, before the compressor, with airflow rates  matching that of the compressor. The dehumidified and compressed air can be used  to achieve lower humidity inside the HBAT chamber.
  3. The flexible pipe from the compressor to the chamber is quite long. We could take a  small fridge, and modify it to have an inlet and outlet hole on one wall, through  which the majority of the pipe can be put inside the chamber to be cooled thoroughly  before it opens inside the chamber. That would minimize air-conditioning costs and  even do away with the need for a dedicated room
  4. The HBAT room containing the chamber should have a small exhaust fan, with its air  inlet opening onto a pipe whose other end is brought down to open in a funnel like

fashion close to the twin exhaust valves of the soft chamber. This will reduce the  recirculation of stale air inside the air-conditioned room and chamber and help  maintain the CO2 levels closer to physiologically normal inside the HBAT chamber.  What next?  

  • How many can afford HBOT at its present cost level even in the economically  advanced USA? Not a great many, except in the states where Medicaid has allowed  re-imbursement as a follow up of the Steele child court case in Georgia in 2006.
  • Now think how many can afford costly regular HBOT in India and other similar not  so developed countries which do not have any reimbursement for “experimental  HBOT” in CP children? The soft chambers are “Not ASME-PVHO” compliant.
  • Do we tell them: “Either go in for regular HBOT only, or Get Lost?”  • We need the option of an economical monoplace HBAT chamber that can deliver 1.3  ATA room air at an economical rate, which can run even on a small Electrical  generator (because electricity load-shedding is endemic in countries like ours) with a  dehumidifier AND an air cooling device INLINE.
  • Such an equipment, used by trained personnel under medical supervision, in properly  investigated, selected and adequately followed up cases, should not need permission  from Dept. of Explosives, Dept. of Drugs and the Fire Safety guys because NO  FIRE-SAFETY NORMS ARE VIOLATED AND NO EXPLOSIVE OXYGEN IS  USED.
  • The pressure used in such low pressure chambers is less then the pressure differences  experienced in any commercial airline (0.5 ATA down when ascending and the same  up while descending to land). The pressure increase is equal to that experienced when  diving into a standard swimming pool to a depth of only 10 feet or 3 meters.  Our Dilemma  

What pressure do we recommend to a particular child? That is a hard decision we must take,  especially as the much more affordable 1.3 ATA gives statistically similar benefit at almost  half the cost, which many more parents in the less economically affluent segments can afford.  We would categorically like to clarify that we are NOT RECOMMENDING any particular  chamber, but merely discussing different pressure effects in Indian Children, with their lower  body weight and metabolic activity, with our experience limited to regular HBOT at 1.5 ATA  and 1.75 ATA, and also at 1.3 ATA inside an OxyHealth soft chamber, with their limitations  and benefits, in CP children.

We do not, repeat, DO NOT, advocate the use of 100% Oxygen or an oxygen concentrator  with NON-ASME PVHO chambers, as we have no experience with it nor have any plans to  do so in future.

The mHBOT data we have shown have been with compressed room air only. In fact, the  notice on the side of the chamber clearly states that these chambers are not recommended by  their manufacturer to be inflated with Oxygen.

Our position  

Our data in 128 CP children treated and followed up for 6-8 month is not enough to make an  authoritative recommendation even though our preliminary data suggest that improvements  seen with Hyperbaric Therapy in all it’s three tested forms is very encouraging, and we  should continue the study further.

We believe that we require more supportive data to show that the use of 1.3 ATA may be an  option to parents who cannot afford the higher cost of 1.5 ATA, to get a fair degree of  improvement in the quality of life of their kids. We also need to develop protocols to select  the children who would definitely do better on the low-pressure regimen. It is possible that  the CP child with greater motor dysfunction will be slightly better off with regular HBOT

while the ones with significant cognitive impairment will do better with low pressure HBAT.  Only time will tell us a more definitive answer.

Our ongoing research should have more data on this aspect in another 2 to 3 years.

Conclusions  

We have carried out an ongoing open non-randomized controlled prospective study of  management of CP children with intensive one-to-one standard therapies, supplemented in 60  children with 1.75 ATA HBOT, in 24 CP children with 1.5 ATA HBOT and in 24 CP  children with 1.3 ATA HBAT.

The four groups were matching in age, age distribution, sex distribution and initial severity.  They were assessed at 4 and 6 months. Most children also had serial video recordings also.  All three hyperbaric therapy groups induced significant improvement over the Control group  in Cognitive & Speech / Communication parameters within 4 months. The early response as  compared to motor response could be due to the shorter intra-cranial axons responsible,  which re-myelinate faster after HBOT.

The Cognitive and Speech / Communication skill changes appeared to be permanent during  our longer-term follow-up of 6 to 8 months or more.

Improvements in Physical (GMFM) Parameters reach significance after 4th months, though  our clinical impression is that it peaks after 6 to 8 months. The greater response time required  for clinically significant motor achievements could be due to the longer time needed to  remyelinate the long Pyramidal tract from brain to lower spinal motor neurons. The gains in  Physical Controls appear to be permanent

Re-spasticity occurs at limbs due to reduced ability of spastic muscles to lengthen on par with  normal muscles during bone lengthening as per age related growth. Intensive OT/PT till at  least 21 years of age may reduce extent of re-spasticity in those children who are doing it.  We showed at the 5th Symposium on HBOT (Florida) in 2006 that the preferred age for  HBOT in CP is 1-4 years, before brain development, dendritic arborization, synaptic  development, cerebral sphyngomyelin & cholesterol concentrations complete. However,  encouraging statistically significant improvements was also seen older children, due to their  higher level of understanding, cooperation and self-motivation.

Our data suggests that a minimum of 4 months, preferably 6 months, of follow up is needed  to show significant cognitive, and later, motor improvements.

Just as a normal child needs up to 4 years for his full Neuro-development, so does a CP child  given HBOT, whose “TIME” starts six months after completing HBOT, when remyelination  is complete.

How many HBOTs?  

We suggest that parents carry on intermittent HBOT (40 sessions at a time) as long as the  GMFM development curve shows significant upward deviation (more than about 1 point per  month).

Our Final Conclusion  

CP is a multifactorial ischemic brain pathology with motor deficiencies, besides variable  degrees of cognitive, sensory, communication and visual deficiencies.

Based on the data we have gathered so far, we feel that in the medical intervention therapy of  CP children receiving intensive Standard Therapy with supplemental Hyperbaric Therapy  gives a statistically significant benefit as compared to children receiving only similar  Standard Therapy.

Also that 1.3 ATA Low pressure Hyperbaric Air Therapy is Statistically Not Inferior to  Regular HBOT at 1.5 / 1.75 ATA using 100% oxygen.

Further study over the next 2 to 3 years may shed more light on this evidence.