Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

NCT03339037 | Terminated

• 1 other identifier: 0120-16-ASF
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms. The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated. The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.

Conditions

Hyperbaric Oxygen Therapy; Traumatic Brain Injury; Post-Concussion Syndrome

Keywords

HBOT; TBI; pediatrics; PCS; PPCS; concussion; traumatic brain injury; hyperbaric oxygen

Outcome Measures

Primary Outcomes (2)

• Cognitive function

  General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).

  at 3 months

• Cognitive function

  General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).

  at 6 months

Secondary Outcomes (10)

• Post concussion syndrome symptoms

  baseline, 3 months and 6 months from baseline

• Health Behaviour inventory

  baseline, 3 months and 6 months from baseline

• Balance

  baseline, 3 months and 6 months from baseline

• Brain functional imaging

  baseline, 3 months

• Brain microstructural imaging

  baseline, 3 months and 6 months from baseline

Study Arms (2)

Hyperbaric oxygen therapy

ACTIVE COMPARATOR

60 Hyperbaric oxygen sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). each session 1.5 ATA of 100% oxygen for 1 hour. 1 meter per minute compression and decompression.

Device: Hyperbaric oxygen therapy

Normobaric air SHAM

SHAM COMPARATOR

60 sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session at 1 ATA of 21% oxygen (air) for 1 hour. 1 meter per minute compression and decompression. after 3 months, patients will be crossed over and treated with 60 sessions of treatment

Device: Normobaric air SHAM

Interventions

Hyperbaric oxygen therapy DEVICE

60 HBOT sessions at 2 ATA 100% oxygen

Hyperbaric oxygen therapy

Normobaric air SHAM DEVICE

60 sessions at 1 ATA 21% oxygen (air)

Normobaric air SHAM

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Ages 8-15
• Moderate TBI -Patients with a GCS of 9-12 a as well as additional criteria such as CT abnormalities and admission to hospital
• Presence of at least two PCS as measured by the Post-Concussion Symptom Inventory )see attached) (there's a RCT now recruitingwith at least 1 and not 2) for at least 3 months.
• No change in cognitive or behavioral functions during one month prior to the beginning of the study (according to parents/teachers report).
• Screening protocol:
• \- Objective cognitive impairment: a decrease of at least 1 standard deviation (SD) from same age mean score in one or more of the following indices : memory, attention, information processing speed, executive functions in both Neurotrax

You may not qualify if:

• \- Dynamic neurologic improvement or worsening during the past month (according to parents/teachers report);
• Chest pathology incompatible with pressure changes (including asthma)
• Inner ear disease;
• Claustrophobia;
• Inability to perform awake brain MRI test
• Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.)
• Brain tumors
• Skull base fractures
• Active malignancy
• s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, won't be excluded.
• Encephalomalacia per MRI imaging
• No informed consent

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Shai a Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization by computer, sham/ treatment will be known to chamber technicians and nurses but not to investigators
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: randomized controlled trial using a SHAM treatment compared to treatment

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: November 13, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: May 20, 2022
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)