Status:
TERMINATED
Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Hyperbaric Oxygen Therapy
Traumatic Brain Injury
Eligibility:
All Genders
8-16 years
Phase:
NA
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 o...
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 neur...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03339037
Start Date
November 1 2017
End Date
May 20 2022
Last Update
July 3 2024
Active Locations (1)
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1
Assaf-Harofeh Medical Center
Ẕerifin, Israel, 70300