Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke

University of Utah1 个研究点分布在 1 个国家目标入组 51 人开始时间: 2023年6月29日最近更新: 2026年5月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Utah
入组人数: 51
试验地点: 1
主要终点: Transcranial magnetic stimulation to evaluate corticospinal transmission

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Researchers at the University of Pittsburgh are conducting a research study to see how combining brain, nerve, and hand stimulation affect hand movement after stroke. The primary purpose of this study is to examine changes in the connection between the brain and the weak hand muscles after the combined brain, nerve, and hand stimulation. The primary hypothesis is that the combined brain, nerve, and hand stimulation will increase the the connection between the brain and the weak hand muscles. The secondary purpose of this study is to examine changes in weak hand's movement and function after the combined brain, nerve, and hand stimulation. The secondary hypothesis is that the combined brain, nerve, and hand stimulation will increase weak hand movement and function.

详细描述

A total of 40 participants will be enrolled in this study. During the intervention sessions, Participants will receive three combinations of the brain, hand, and nerve stimulations.

Each participant will complete three intervention sessions for the short-term effect of the intervention. The time between sessions is 3-7 days. After data collection is completed for the short-term effect part of the study, 5 out of 40 participants will be randomly chosen to enroll in the long-term effect part of the intervention. Those participants will take part in 18 intervention sessions. The sessions will be administered three times a week for six weeks.

In the short-term effect part of the study, participants will complete the following three sessions:

Repeated brain, hand, and nerve stimulations while practicing a task. In this session, participants will receive 120 pairs of brain, hand, and nerve stimulation while repeatedly grasp and release a ball with the weak hand. The hand stimulation will help participants to release the ball.
Repeated brain and nerve stimulations during rest. In this session, participants will receive 120 pairs of brain and nerve stimulation while the weak hand is resting (or not performing a task).
Hand stimulation while practicing a task. In this session, participants will practice grasping and releasing the task 120 times with hand stimulation. The hand stimulation will help participants to release the ball.

In the long-term effect part of the study, participants will complete the following session (3/week for 6 weeks):

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Single (Participant)

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

•Age between 18-85 years
•Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
•Stroke onset of at least six months prior to the time of participation
•A score of at least 1 out of 2 on the spherical grasping item of the Fugl-Meyer Upper Extremity Subscale to allow participants to grasp the ball
•Cognitive skills to actively participate, as indicated by scores of > 23 on the Mini-Mental Status Examination
•English speaking

排除标准

•Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction
•Presence of severe aphasia
•Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2
•Diagnosis of neurological disorders other than stroke
•History of seizure or epilepsy
•Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
•Presence of metallic implants in the head or neck
•Currently or planning to become pregnant
•Difficulty maintaining alertness or remaining still
•Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI)
•Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
•Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
•Life expectancy less than the duration of the study
•Excessive pain in the paretic hand, defined as a Visual Analog Scale Score >4
•Participation in concurrent occupational therapy
•Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA)

研究组 & 干预措施

Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS

Experimental

During Task-specific paired corticospinal-motor neuronal stimulation (PCMS) participants will receive PCMS [Transcranial Magnetic Stimulation (TMS) + Peripheral Nerve Stimulation (PNS)] with task-specific practice.

During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.