Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
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.
Condition:
Hyperbaric Oxygen Therapy
Treatment:
Hyperbaric oxygen therapy
Start Date:
November 1, 2017
Sponsor:
Assaf-Harofeh Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT03339037