KTMP: A Novel Method of Non-invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fugl Meyer Assessment
研究概览
简要总结
kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-80 years old who have had a stroke resulting in hemiplegia
- •Ability to communicate, understand, and give appropriate consent
- •Other criteria may apply
排除标准
- •Significant cognitive impairment
- •inability to adhere to the study protocol or provide informed consent
- •pregnancy
- •additional criteria may apply
研究组 & 干预措施
Active Treatment
Active treatment with kTMP for 18 weeks
干预措施: kTMP 18 weeks (Device)
Crossover Treatment
Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment.
干预措施: kTMP sham stimulation 9 weeks + active stimulation 9 weeks (Device)
结局指标
主要结局
Fugl Meyer Assessment
时间窗: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.
The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment.
次要结局
- Wolf Motor Function Test(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- Stroke Impact Scale(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- Stroke Specific QOL(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- EuroQOL(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- Motor Activity Log(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- Modified Ashworth Scale Scores(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)
- Action Research Arm Test(At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34)