PCMS Task After Moderate-to-severe Stroke
- Conditions
- Stroke
- Interventions
- Device: Task-specific PCMSDevice: Task-specific sham-PCMSDevice: PCMS-rest
- Registration Number
- NCT05736653
- Lead Sponsor
- University of Utah
- Brief Summary
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.
- Detailed Description
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:
1. 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.
2. 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).
3. 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):
During the intervention, participants will receive repeated brain, hand, and nerve stimulations while practicing a task. They 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. We will give rest breaks during the practice of the task.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS Task-specific sham-PCMS 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. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific sham-PCMS, Task-specific PCMS PCMS-rest During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific PCMS, Task-specific sham-PCMS Task-specific PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific PCMS, Task-specific sham-PCMS Task-specific sham-PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific sham-PCMS, Task-specific PCMS Task-specific PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific sham-PCMS, Task-specific PCMS Task-specific sham-PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS Task-specific PCMS 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. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific PCMS, Task-specific sham-PCMS, PCMS-rest Task-specific PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific PCMS, Task-specific sham-PCMS, PCMS-rest Task-specific sham-PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific PCMS, Task-specific sham-PCMS, PCMS-rest PCMS-rest During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). PCMS-rest, Task-specific PCMS, Task-specific sham-PCMS PCMS-rest During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, PCMS-rest, Task-specific PCMS Task-specific sham-PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, PCMS-rest, Task-specific PCMS PCMS-rest During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS PCMS-rest 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. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, Task-specific PCMS, PCMS-rest Task-specific PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, Task-specific PCMS, PCMS-rest Task-specific sham-PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, Task-specific PCMS, PCMS-rest PCMS-rest During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS). Task-specific sham-PCMS, PCMS-rest, Task-specific PCMS Task-specific PCMS During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice. During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice. During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
- Primary Outcome Measures
Name Time Method Transcranial magnetic stimulation to evaluate corticospinal transmission Change from baseline up to 30-minutes post intervention Corticospinal transmission will be assessed by examining the percent change of the peak-to-peak motor evoked potential (MEP) amplitude relative to baseline.
- Secondary Outcome Measures
Name Time Method Voluntary force production to evaluate motor performance Change from baseline up to 30-minutes post intervention We will measure force production of the wrist and finger extensors (EDC) to evaluate motor performance using load cells embedded in cushioned customized platforms. Participants will perform isometric wrist and finger extension movements against load cells. We will calculate the percent change of maximum force output.
Maximum finger spread to evaluate motor performance Change from baseline up to 30-minutes post intervention Three-dimensional biomechanical data will be collected to evaluate motor performance using a motion capture system. Reflective markers will be placed on the participant's paretic forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening task. Hand biomechanics will be evaluated by computing the percent change of maximum finger spread during the hand opening task.
Box and Block Test Change from baseline up to 30-minutes post intervention The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. We will calculate the percent change of the total number of blocks transferred in one minute.
Maximum finger excursions to evaluate motor performance Change from baseline up to 30-minutes post intervention Three-dimensional biomechanical data will be collected to evaluate motor performance using a motion capture system. Reflective markers will be placed on the participant's paretic forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening task. Hand biomechanics will be evaluated by computing the percent change of maximum finger excursions during the hand opening task.
Trial Locations
- Locations (1)
Neural Plasticity Rehabilitation and Movement Dynamics Lab
🇺🇸Salt Lake City, Utah, United States