Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

NCT ID: NCT03339037

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2022-05-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hyperbaric oxygen therapy

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.

Group Type: ACTIVE_COMPARATOR

Hyperbaric oxygen therapy

Intervention Type: DEVICE

60 HBOT sessions at 2 ATA 100% oxygen

Normobaric air SHAM

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

Group Type: SHAM_COMPARATOR

Normobaric air SHAM

Intervention Type: DEVICE

60 sessions at 1 ATA 21% oxygen (air)

Interventions

Hyperbaric oxygen therapy

60 HBOT sessions at 2 ATA 100% oxygen

Intervention Type: DEVICE

Normobaric air SHAM

60 sessions at 1 ATA 21% oxygen (air)

Intervention Type: DEVICE

Eligibility Criteria

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:

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shai a Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofhe MC

Locations

Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Other Identifiers

0120-16-ASF

Identifier Type: -

Identifier Source: org_study_id