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NCT03339037

Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

Sponsor: Assaf-Harofeh Medical Center

View on ClinicalTrials.gov

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.

Official title: Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury

Key Details

Gender

All

Age Range

8 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2017-11-01

Completion Date

2022-05-20

Last Updated

2026-04-22

Healthy Volunteers

Conditions

Hyperbaric Oxygen Therapy Traumatic Brain Injury Post-Concussion Syndrome

Interventions

DEVICE

Hyperbaric oxygen therapy

60 HBOT sessions at 2 ATA 100% oxygen

DEVICE

Normobaric air SHAM

60 sessions at 1 ATA 21% oxygen (air)

Inclusion Criteria: * \- Ages 8-15 * Mild TBI (defined as loss of consciousness with duration of 0-30 minutes, post-traumatic amnesia with duration of less than 24 hours, Glasgow Coma Scale grade of 13-15) within 6 months-3 years prior to the inclusion in the study. * 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: After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax in patients over 10, and standard pen and paper cognitive tests in patients under 10. Patients who fulfill inclusion criteria will be included in the study. Inclusion criteria: \- 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 Exclusion Criteria: * \- Dynamic neurologic improvement or worsening during the past month (according to parents/teachers report); * Had been treated with HBOT for any other reason prior to their inclusion; * 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

Locations (1)

Assaf-Harofeh Medical Center

Ẕerifin, Israel