Stimulating After Recovery From Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
研究概览
简要总结
This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.
详细描述
All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to stimulation versus no stimulation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years and older
- •Diagnosis of a mild to moderate TBI (GCS > 8 on admission)
- •Able to perform a computerized assessment
- •Willing to attend all scheduled appointments
- •Able to undergo the informed consent process
- •Healthy participants:
- •Adults 18 years and older
- •Able to perform a computerized assessment
- •Willing to attend all scheduled appointments
- •Able to undergo the informed consent process
排除标准
- •Open wound on scalp
- •Severe TBI diagnosis or GCS of less than 8 on admission
- •Non-English speaking
- •Incarcerated
- •Implanted defibrillator or pacemaker
- •Visual impairment that hinders ability to complete computerized assessments
- •Healthy subject exclusion criteria:
- •Less than 18 years of age
- •Open wound on scalp
- •TBI diagnosis
- •Non-English speaking
- •Incarcerated
- •Implanted defibrillator or pacemaker
- •Visual impairment that hinders ability to complete computerized assessments
研究组 & 干预措施
Sham
No stimulation
干预措施: COGED (Behavioral)
Stimulation
Stimulation
干预措施: External non-invasive stimulation (Combination Product)
Stimulation
Stimulation
干预措施: COGED (Behavioral)
结局指标
主要结局
Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
时间窗: 3 years
Using non-invasive transcranial alternating current stimulation, it will be determined if this study is feasible for improving cognitive recovery after mild to moderate brain injury. To determine the sum total of completion rate of study procedures.
次要结局
未报告次要终点