Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
randomization by computer, sham/ treatment will be known to chamber technicians and nurses but not to investigators
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •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
排除标准
- •- 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
研究组 & 干预措施
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
干预措施: Normobaric air SHAM (Device)
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.
干预措施: Hyperbaric oxygen therapy (Device)
结局指标
主要结局
Cognitive function
时间窗: at 6 months
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
Cognitive function
时间窗: at 3 months
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
次要结局
- Health Behaviour inventory(baseline, 3 months and 6 months from baseline)
- Balance(baseline, 3 months and 6 months from baseline)
- Brain microstructural imaging(baseline, 3 months and 6 months from baseline)
- Executive functions(baseline, 3 months and 6 months from baseline)
- Post concussion syndrome symptoms(baseline, 3 months and 6 months from baseline)
- Brain network analysis(baseline, 3 months and 6 months from baseline)
- Brain functional imaging(baseline, 3 months)
- Brain perfusion(baseline, 3 months and 6 months from baseline)
- Short form health survey (PedsQL)(baseline, 3 months and 6 months from baseline)
- Behaviour(baseline, 3 months and 6 months from baseline)
研究者
Shay Efrati
Prof.
Assaf-Harofeh Medical Center