PCMS Task After Moderate-to-severe Stroke
Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke
2 other identifiers
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2023
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2025
CompletedMay 8, 2026
January 1, 2026
2.7 years
February 10, 2023
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transcranial magnetic stimulation to evaluate corticospinal transmission
Corticospinal transmission will be assessed by examining the percent change of the peak-to-peak motor evoked potential (MEP) amplitude relative to baseline.
Change from baseline up to 30-minutes post intervention
Secondary Outcomes (4)
Voluntary force production to evaluate motor performance
Change from baseline up to 30-minutes post intervention
Maximum finger excursions to evaluate motor performance
Change from baseline up to 30-minutes post intervention
Maximum finger spread to evaluate motor performance
Change from baseline up to 30-minutes post intervention
Box and Block Test
Change from baseline up to 30-minutes post intervention
Study Arms (6)
Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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).
Interventions
120 pairs of sham-PCMS stimuli will be administered during task-specific practice. The TMS coil will be placed \~10 cm behind the participant's head, and PNS electrodes will be placed in the same position as for task-specific PCMS, but no stimulation will be delivered. Like the task-specific PCMS condition, participants will perform the same grasp and release a ball task in an identical manner. FES will be delivered after detecting voluntary EDC activity, similar to the task-specific PCMS condition.
120 pairs of TMS and PNS volleys will be administered with the EDC muscle at rest every 10 s (\~20 min, 0.1 Hz). TMS will be used to elicit motor-evoked potentials (MEPs). Antidromic activation of spinal motor neurons will be elicited by supramaximal peripheral nerve stimulation (PNS) applied to the radial nerve near the elbow. Volleys will be timed to arrive in the spinal cord based on central and peripheral conduction times calculated for each subject so that the pre-synaptic terminal is depolarized via TMS \~1-2 ms before spinal motor neurons are depolarized via PNS at a pulse duration of 200us. We will also perform stimulation of the cervical roots (C-root) by placing the coil behind the neck and stimulating the C-root (C6 and C7 vertebrae), which innervate the finger extensor muscles. Conduction times will be calculated from latencies of the primary motor area (M1) MEP, C-root, and M-wave.
120 pairs of TMS and PNS volleys will be administered during electromyography-triggered functional electrical stimulation (FES)-assisted task-specific training (task-specific PCMS). In the task-specific PCMS, participants will first grasp a spherical ball when prompted by an auditory 'Ready' cue, and upon seeing a visual 'Go' cue will voluntarily extend the wrist and fingers to release the ball. After the 'Go cue', our customized stimulation delivery algorithm triggers the TMS and PNS only when the extensor digitorum communis (EDC) muscle activity exceeds a pre-determined threshold. The algorithm will then trigger FES to EDC after detecting EDC activity (\~2 ms after PNS) for the next 2 seconds, allowing the pairing of PCMS (TMS and PNS) with the voluntary movement of EDC without the confounding effects of FES.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neural Plasticity Rehabilitation and Movement Dynamics Lab
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Sethi, PhD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
March 29, 2023
Primary Completion
December 21, 2025
Study Completion
December 21, 2025
Last Updated
May 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share