Summary: Newer concepts in the pathophysiology and investigations in Autism Spectrum disorders have shown that many of the medical problems associated with or aggravating autistic traits, can be overcome to a variable extent, to enhance quality of life of children with autism, though cure may not be available due to the inborn multi-genetic problem. New tests are available to rule out many cases of inborn errors of metabolism and many genetic defects. Modern early medical intervention therapy with regulated diet, avoiding allergens, treating allergies and infections in gut and appropriate micronutrient support. Some children have inability to transform Vitamin B12 to Methyl B12, which is needed for neural activity and subsequently glutathione formation. Most such children are deficient in MTHFR Enzyme and can be helped in most cases by giving vitamin MB12 subcutaneous injections. Many ASD children genetically lack the capacity for efficient excretion of heavy metals like mercury.  After proper identification of heavy metal load, these children may be helped by appropriate chelation therapy. SPECT Scans can show children who have developed perfusion defect in brain due to the multiple ASD pathologies. They may be helped where appropriate with the help of low pressure Hyperbaric air. The UDAAN Multimode Early Medical Intervention Therapy Project, hopefully starting April 2007, after necessary Ethics Committee approval and Drugs Controller of India permission, aims to study these avenues in more scientific detail, at a cost that many Indian families may be able to afford. Last updated June 19, 2007

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Introduction

The interventions planned include 

Phase 1: Daily Standard Therapy (SI, OT, Speech Therapy, Special Education) mandatory throughout. Detailed assessment using Internationally approved scales. Thorough medical checkup as per guidelines available from ARI Website, to try and identify symptom aggravating genetic defects / inborn errors of metabolism and allergens. Appropriate dietary guidelines and allergen avoidance, including examining if a GFCF Diet helps the child. Detecting and treating all intercurrent infections. Supplementing the proper balanced hypo-allergenic diet with a herbal health supplement known to improve brain activity, obtained from Hamdard University under a collaborative research agreement (khajoor, badaam, amla, kali mirch and brahmi)....... Proposed duration: 3 to 4 months.

Phase 2 (after 3 to 4 months of above): Re-assess to gauge progress with Phase I Therapy. Then, identify children deficient in MTHFR Enzyme and with high levels of Homocysteine. Give them subcutaneous vitamin MB12 injections as per protocol (Awaiting approval by Regulatory Authorities in Govt.). Standard Therapy and Dietary guidelines as above to continue. ...... Proposed duration: 3-4 months.

Phase 3 (after 3 to 4 months of above): Re-assess to gauge progress with Phase I  and II Therapy. Then, identify children overloaded with heavy metals by doing appropriate blood tests and DMPS challenge Urinary metal excretion assessment. Those children found to be overloaded in toxic heavy metals will be given chelation therapy under stringent medical supervision, regular blood tests, re-assessments, serial video and clinical recording. ...... Proposed duration: 2 years or whenever urine tests become negative, whichever is earlier.

Phase 4 (after 1 to 3 months of above): Re-assess to gauge progress with Phase I, II and III Therapy. Then, identify children with brain perfusion defects on SPECT Scan of brain, and give low pressure Hyperbaric Air Therapy to enhance brain perfusion, under stringent medical supervision, regular blood tests, re-assessments, serial video and clinical recording. ...... Proposed duration: 100 one-a-day sessions, divided into batches of 20, separated by a gap of two months each. 

Click here to see Protocol for Methodologies to be followed

Duration parents with children need to stay at South Delhi:

1. One week every 3 months from May 2007 to May 2009, for periodic assessments, laboratory tests and handing over of necessary drugs, vitamin and mineral supplements.
2. One month at a time for the one month of HBA, to be repeated 5 times with a gap of 2 months in-between for 5 rounds.

Special Facilities to be made available to enrolled children:

1. MB12 subcutaneous injections, 1 ml vials containing thimerosal-free 10 mg/ml MB12 initially and 25 mg/ml later on if thought necessary. It has been prepared especially for this project by an Indian Pharma giant, and is currently under legal procedures for regulatory permission.. The drug will be injected using BD  Insulin Syringes with 32 gauge 4 mm needles. We hope to provide the drug and syringes at raw material price only, which will be a tiny fraction of International price.
2. DMPS capsules for Oral/Rectal use, 50 mg each, again at raw material price, will be made available for this project only, courtesy of the same Pharma giant. We have decided not to use Intravenous DMPS because of the long term need in small children, where veins would be at a premium. We have also decided not to use TD-DMPS, because of its erratic results as per personal communication with various experts in medical Intervention for Autism, and other authorities met at the 5th Int. Symposium on HBOT and the Recoverable Brain.
3. Children with Autism have decreased level of Anti-Oxidants like Glutathione, SOD, etc. This enhances inflammatory injury in selected areas of neural tissues in brain, as seen in SPECT and fMRI Scan of Brain. Because of their (autism affected children) extra vulnerability to Free Radical damage, Dr. Dan Rosignol recommends that they be given HBA at 1.3 ATA using room air (20% Oxygen) only. UDAAN has the necessary Hyperbaric chamber, specifically built to these specifications, with a second one on its way within a month or two.
4. Diet guidelines will be provided by an experienced Dietician
5. Health care will be looked after by Dr. MS Ray, MBBS, MD (Pediatrics) and Dr. A Mukherjee, MBBS, MD (Internal Medicine).
6. During the one month stay at Delhi for each of the five rounds of Low Pressure HBA, special arrangements for Standard Therapy (Special Education, SI, OT and Speech) have been made at a new dedicated equipped center, providing one-to-one therapy by Special Educators, Occupational Therapists and Speech Therapists experienced in handling autistic children.
7. Children staying on at Delhi may avail of continued one-to-one therapy, if vacancy exists in the time slots.
8. Arrangements are being worked out with an Internationally affiliated International Standard Laboratory at Delhi, for carrying out the specialized tests necessary for this project. Because of our mass scale work, we have managed to get about 25% concession for these tests.

Accommodation

1. UDAAN does not have a Guest House.
2. Nearby decent, clean, affordable middle class guest houses at Chittaranjan Park area of South Delhi are available for Rs.400 per day, with a 10 % concession for longer stay. Most parents opt to stay there. They also have A/c rooms @ Rs.800 to 1200 per day. Food cost extra. Rooms with better facility and locality can be arranged at higher cost if that is what the parent wants for the quarterly one week assessment stay or one month stay during HBA therapy.
3. Unfortunately, rented accommodation for 1 month every 3 months may be a problem in getting, though we are trying to work something out.
4. Considering that only 1 month x 5 rounds, at 3 month intervals, is needed for the HBOT phase, please do try to cajole a relative or friend at Delhi to help you out as a "Paying Guest".

Special Facility for all Children with Autism in India, even though they may not be a part of the UDAAN Project

1. Any child with Autism, whether or not a part of the research project, may avail of the checkup facilities through us at Delhi.
2. Children who have already started DAN protocol and Chelation for at least 6 months, may get their low pressure HBA done at UDAAN, subject to availability of spare time (limited seats). The cost of each session is Rs.850. We propose to give 80 to 100 sessions, in lots of 20 to 40, with about 2 month gaps in-between.

Proposed Start date: April 2007 (subject to getting approval of Govt. Regulatory Authrities)

Click here to see the Proposed Study Protocol (Subject to modifications as demanded by Drugs Controller General of India and the Institutional Ethics Committee of Hamdard University, from time to time, if required by them).

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