NCT02125591撤回不适用
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial
U.S. Army Medical Research and Development Command4 个研究点 分布在 1 个国家开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Change in Sensory Organization Test (SOT)
研究概览
简要总结
The purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran or Servicemember
- •18 to 50 years old
- •Sustained one or more mild traumatic brain injury (mTBI)s
- •Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample))
- •Available for the duration of the study
排除标准
- •History of traumatic brain injury (TBI) of any severity other than mild TBI
- •Presence of active substance abuse condition
- •Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
- •Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
- •Orthostatic hypotension as defined by:
- •A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
- •A diastolic blood pressure decrease of at least 10 mmHg, or
- •A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion
- •An implanted medical device
- •Oral infection
- •Known transmissible disease (HIV, hepatitis, influenza, TB)
- •Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
结局指标
主要结局
Change in Sensory Organization Test (SOT)
时间窗: 12 weeks
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
次要结局
- Change in neuroimaging using functional magnetic resonance imaging (fMRI)(12 weeks)
- Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)(12 weeks)
- Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)(12 weeks)
- Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)(12 weeks)
- Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)(12 weeks)
- Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)(12 weeks)
- Change in quality of life measured using Short Form 36 (SF-36)(12 weeks)
研究者
研究点 (4)
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