NCT03339037

Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed as a prospective, randomized, controlled, cross-over two groups trial. The study will be conducted in the -Sagol center for hyperbaric medicine and research and the children neurological unit of Assaf Harofeh Medical Center, Israel. Brain MRIs evaluation will be done the radiology department of Assaf-Harofeh Medical Center, Israel. Study will include 70 patients After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax and Moxo cognitive batteries. Patients who fulfill inclusion criteria will be included in the study. After signing informed consent (by parents, at the prescreening phase), patients who fill inclusion criteria, will be randomized in 1:1 manner into the treated or the control-cross group. Randomization will be performed using a computer software according to patient id. After the randomization, patients will be invited for baseline evaluation that will include full review of their medical status and complete physical examination. All patients will go through evaluation of their neurocognitive function using further neurocognitive testing battery, questionnaires and brain imaging (perfusion MRI+DTI, SPECT). In cases of brain tumors, skull base tumors, encephalomalacia findings in MRI, patients will be excluded. The patients in the treated group will be evaluated three time - at baseline, after 3 months of HBOT treatment and after another consequent 3 months period from treatment (6 months from baseline). The patients of the cross group will be evaluated three times as well- at baseline, after 3 month control period without hyperbaric treatment and after a consequent 3 month period of HBOT treatment. The following HBOT treatment protocol will be practiced: The patients will go through 60 HBOT treatments (each treatment session will be given on a separate day), distributed over three months (five days a week). Each session will be for 60 minutes in 100% oxygen atmosphere and at pressure of 1.5 ATA.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Hyperbaric oxygen therapy	60 HBOT sessions at 2 ATA 100% oxygen
DEVICE	Normobaric air SHAM	60 sessions at 1 ATA 21% oxygen (air)

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-11-01
• Completion: 2022-05-20
• First posted: 2017-11-13
• Last updated: 2024-07-03

Locations

1 site across 1 country: Israel