Hyperbaric Oxygen Treatment in Autism Spectrum Disorders

Effect of Hyperbaric Oxygen Therapy (HBOT) in Children With Autism Spectrum Disorder (ASD)

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.

Study Overview

• Status: Recruiting
• Conditions: Child Autism
• Intervention / Treatment: Device: Hyperbaric oxygen Therapy HBOT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hedi Gharsallah, Doctor; Phone Number: 00216 71391885; Email: gharsallahhedi@gmail.com
• Study Contact Backup: Name: Hela Slama, Doctor; Phone Number: 00216 29407348; Email: slamahela2003@yahoo.fr

Study Locations

• Tunisia
  • Montfleury
    • Tunis, Montfleury, Tunisia, 1008
      • Recruiting
      • HBOT Department Military Hospital
      • Contact: Hedi Gharsallah, MD; Phone Number: 00216 71390885; Email: gharsallahhedi@gmail.com
      • Contact: Hela Slama, MD
      • Sub-Investigator: Emna Cherif, MD
      • Sub-Investigator: Mouna Azeiz, MD
      • Sub-Investigator: Manel Ayoub, PH
      • Sub-Investigator: Imen Mzoughi, MD
      • Sub-Investigator: Lamjed Msoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBOT Group; will benefit from HBOT	Device: 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%
No Intervention: Control group; will benefit from the conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical severity assesement	Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)	03 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dosage of Inetreleukine 6	Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: IL6	03 months
dosage of TNFα	Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: TNFα	03 months
Oxidatif stress profil	Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Total antioxidant status (SAT)	03 months
dosage of Glutathione peroxidase	Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Glutathione peroxidase	03 months

Collaborators and Investigators

• Sponsor: General Administration of Military Health, Tunisia
• Collaborators: Military Hospital of Tunis

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ASD - HBOT -
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: autism spectrum disorder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No