Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
研究概览
简要总结
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.
Specific Aims:
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Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury.
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Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
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Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
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Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
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Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional
- •Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ).
排除标准
- •Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:
- •COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs
- •Current pneumothorax or previous spontaneous pneumothorax
- •Uncontrolled HTN (systolic >180 or diastolic >100)
- •Known Ejection fraction < 35%
- •Pacemaker / ICD in place (not approved for chamber use)
- •Hematological/Oncological:
- •Current chemotherapeutic drug use, and past history of bleomycin use.
- •Hereditary Spherocytosis
- •Sickle cell anemia
- •Neurological and Psychological:
- •Implanted nerve stimulators
- •Uncontrolled seizure disorder
- •Drug or alcohol abuse/dependence
- •Current treatment for alcohol cessation with disulfiram
- •Claustrophobia
- •Head and Neck:
- •Inability to equilibrate the pressure of middle ears and sinuses
- •Current or previous retinal detachment
- •Retinal or vitreous surgery within the past 3 months
- •Miscellaneous:
- •Current fever or active infection
- •Implanted devices not on the approved list for use with HBOT
- •Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for >2 years.
- •Undergoing vestibular or other therapy during the intervention
- •Planning a change in medication during the intervention
- •Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.
- •Optic neuritis
- •Otosclerosis surgery
- •Thoracic surgery
- •Chronic sinusitis
- •Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.
- •Antabuse - Predisposes to oxygen toxicity
- •Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria
- •Meclizine - Predisposes to oxygen toxicity
- •Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment.
- •Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings.
- •Narcotics - Can lead to cessation of the hypoxic respiratory drive.
- •Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory.
- •Penicillin - Predisposes to oxygen toxicity
- •Promethazine (Phenergan) - Predisposes to oxygen toxicity.
- •Corticosteroids - Decreases the threshold for oxygen toxicity.
- •Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.
结局指标
主要结局
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
时间窗: Baseline, 1 month after treatment
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
次要结局
- Change in quality of life as measured by the Short Form Survey (SF-36)(Baseline, 1 month)
- Number of participants who missed the treatment(5 weeks)
- Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)(Baseline, 1 month after treatment)
- Global Impression of Change (GIC)(Baseline, 1 month post-treatment)
- Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating(Baseline)
- Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.(Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment))
- Number of participants with adverse events(1 month after treatment)
- Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating(Baseline, 1 month post-treatment)
- Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale(Baseline, 1 month after treatment)
研究者
James Berry
Professor- Anesthesiology & Pain Mgmt
University of Texas Southwestern Medical Center