Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
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
- Recruitment rate
研究概览
简要总结
The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility.
- Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase.
- Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed.
- Useability: all therapists and subjects must rate useability as good or better.
- Success of blind: subject accuracy at guessing group membership must be at or near 50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
Recruitment rate
时间窗: 36 weeks
Number and percentage of subjects recruited over the 36 week pilot recruitment phase
Completion and compliance rates
时间窗: Up to 12 weeks
Number and percentage of subjects who complete the study
Usability rating
时间窗: 12 weeks
Number and percentage of subjects and therapists who rated usability as good or better.
Success of blinding
时间窗: 12 weeks
Number and percentage of subjects who accurately guess group membership
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
未报告次要终点