kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Movement Quality Index (MQI)
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.
详细描述
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、研究者、结局评估者)
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 aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
排除标准
- Participants with moderate or severe cognitive impairment (MMSE < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
- 9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
研究组 & 干预措施
Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
干预措施: Sham kTMP (Device)
Active kTMP
Participants received 8 V/m of active stimulation
干预措施: kTMP (Device)
结局指标
主要结局
Movement Quality Index (MQI)
时间窗: Enrollment, then weeks 4, 6, 10, 18, 30
Kinematic data will be captured using a markerless, three-camera motion tracking system during a standardized reach-to-grasp task, with 30 trials per assessment. The cameras will reconstruct 3D hand, arm, and shoulder motion. The primary outcome is change from baseline in the Movement Quality Index (MQI), compared between kTMP and sham groups. MQI is a composite kinematic score calculated as range of motion (ROM) divided by trial-to-trial variability (T2TV), both derived from the 3D reconstructions: ROM: range, speed, and smoothness of hand/arm motion, including elbow and shoulder joint angles. T2TV: consistency across trials, measured as variance of 3D trajectories around the mean trajectory.
Range of Joint Motion (ROM)
时间窗: 6 weeks
defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis
次要结局
- Fugl- Meyer Assessment (Upper Extremity) FMA-UE(Enrollment, then weeks 4, 6, 10, 18, 30)
- Modified Ashworth Scale (MAS)(Enrollment, then weeks 4, 6, 10, 18, 30)
- Stroke Impact Scale (SIS)(Enrollment, then weeks 4, 6, 10, 18, 30)
- EuroQOL (EQ-5D)(Enrollment, then weeks 4, 6, 10, 18, 30)
- Motor Activity Log (MAL)(Enrollment, then weeks 4, 6, 10, 18, 30)
- Wolf Motor Function Test (WMFT)(Enrollment, then weeks 4, 6, 10, 18, 30)
- Stroke Specific QOL (SSQOL)(At enrollment, then weeks 4, 6, 10, 18, and 30)
- Grasp to Lift Time(6 weeks)
- Fugl- Meyer Assessment (Upper Extremity)(6 weeks)
- Modified Ashworth Scale (MAS)(6 weeks)
- Transport Time(6 weeks)
- Trial to Trial Variability (T2TV)(6 weeks)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07631078
- 其他研究编号
- kTMPstrokePilot
日期
- 首次提交
- (4个月前)
- 首次发布
- (3个月前)
- 主要完成日期
- (5个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否