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StrokeNCT05736653

PCMS Task After Moderate-to-severe Stroke

A study testing Task-specific PCMS and PCMS-rest in people with Stroke, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Task-specific PCMS and PCMS-rest
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteUnited States
Study dates
29 Jun 2023to 21 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Neural Plasticity Rehabilitation and Movement Dynamics Lab

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Task-specific PCMS, Task-specific sham-PCMS, PCMS-rest
Keywords
Stroke, Hand, Brain stimulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Task-specific PCMSDevice

    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.

  • Task-specific sham-PCMSDevice

    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.

  • PCMS-restDevice

    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.

Study groups in NCT05736653
Study groupRoleWhat they receive
Task-specific PCMS, PCMS-rest, Task-specific sham-PCMSExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest
Task-specific PCMS, Task-specific sham-PCMS, PCMS-restExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest
PCMS-rest, Task-specific PCMS, Task-specific sham-PCMSExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest
PCMS-rest, Task-specific sham-PCMS, Task-specific PCMSExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest
Task-specific sham-PCMS, Task-specific PCMS, PCMS-restExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest
Task-specific sham-PCMS, PCMS-rest, Task-specific PCMSExperimentalDuring 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).
Receives: Device: Task-specific PCMS; Device: Task-specific sham-PCMS; Device: PCMS-rest

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline up to 30-minutes post intervention

Secondary outcomes (4)
  1. Voluntary force production to evaluate motor performance

    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.

    Measured: Change from baseline up to 30-minutes post intervention

  2. Maximum finger excursions to evaluate motor performance

    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.

    Measured: Change from baseline up to 30-minutes post intervention

  3. Maximum finger spread to evaluate motor performance

    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.

    Measured: Change from baseline up to 30-minutes post intervention

  4. Box and Block Test

    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.

    Measured: Change from baseline up to 30-minutes post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start29 Jun 2023
  3. Primary completion21 Dec 2025
  4. Study completion21 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
We will employ a single group pre-post design.
Masking
Single blind
Who is masked
Participant
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05736653
Sponsor's protocol ID
00179089
Other IDs
R21HD108462
Status last verified
May 2026
First submitted
10 Feb 2023
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Task-specific PCMS and PCMS-rest in people with Stroke, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcranial magnetic stimulation to evaluate corticospinal transmission (time frame: Change from baseline up to 30-minutes post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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