Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03339037
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2017-10-22
Brief Title:
Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment difficulties - patients refusal to sham controlled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBIPED
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
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 11 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 MRIDTI 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 15 ATA
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 11 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 MRIDTI 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 15 ATA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None