Hyperbaric Oxygen Treatment in Autism Spectrum Disorders

NCT ID: NCT04472780

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-10-01

Brief Summary

Hyperbaric oxygen therapy (HBOT) is part of a multidisciplinary therapeutic management of infant autism including psychotherapy, drug treatment and other therapeutics (speech therapy, occupational therapy restrictive diet ...).

It has been postulated that children with autism may benefit from HBOT due to the potential increase in cerebral perfusion occurring during treatment.

In fact, inhaling oxygen above atmospheric pressure could cause an increase in the arterial partial pressure of oxygen, leading to increased oxygen supply to the brain. HBO may also have anti-inflammatory properties due to the reduction in pro-inflammatory cytokines (tumor necrosis factor -α, interferon-γ and interleukins1 and 6). In addition, HBOT could improve mitochondrial dysfunction effects, as well as upregulate the production of antioxidant enzymes.Thus, hyperbaric oxygen therapy could be tried among the therapeutic arsenal of adjuvant treatments for autism.

Detailed Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interactions. People with ASD often exhibit difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity, inattention, impulsivity, self-harm ..

The increasing prevalence of autism spectrum disorders (approximately 1%) has increased the need for evidence-based treatment to lessen the impact of symptoms.

The ethiopathogenesis of ASD has so far been unclear. Current pathophysiological theories have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune dysregulation and oxidative stress involved in the genesis of this disorder. Based on its anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy has been tried as one of the therapeutic arsenals of adjuvant therapy for autism.

This is a randomized controlled study including nearly 80 patients with ASD who underwent clinical and neuropsychological evaluation before and after HBOT treatment as well as the dosage of the various biochemical and immunological markers. These markers will be assessed before and after the HBOT. Perfusion MRI would also be performed before and after HBO.

Conditions

Child Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HBOT Group

will benefit from HBOT

Group Type: EXPERIMENTAL

Hyperbaric oxygen Therapy HBOT

Intervention Type: DEVICE

HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100%

Control group

will benefit from the conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric oxygen Therapy HBOT

HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100%

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of ASD. This diagnosis was made by child psychiatrists experienced in autism using the DSM-5 criteria and the ADI and the Childhood Autism Rating Scale (CARS)

Criteria for non-inclusion :

• Children with hearing or visual impairments
• Children with unbalanced epilepsy
• Children with a contraindication to HBOT
• Dysfunction of the immune system

Exclusion Criteria

-Child that havent completed entire protocol

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Hospital of Tunis

OTHER

Sponsor Role: collaborator

General Administration of Military Health, Tunisia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HBOT Department Military Hospital

Tunis, Montfleury, Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Hedi Gharsallah, Doctor

Role: CONTACT

gharsallahhedi@gmail.com

71391885 ext. 00216

Hela Slama, Doctor

Role: CONTACT

slamahela2003@yahoo.fr

29407348 ext. 00216

Facility Contacts

Hedi Gharsallah, MD

Role: primary

gharsallahhedi@gmail.com

71390885 ext. 00216

Hela Slama, MD

Role: backup

Other Identifiers

Autism spectrum disorder

Identifier Type: -

Identifier Source: org_study_id