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Completed

NCT Number: NCT05736653

PCMS Task After Moderate-to-severe 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neural Plasticity Rehabilitation and Movement Dynamics Lab

Salt Lake City, Utah, 84108, United States

About this study

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):

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Task-specific PCMS

Device

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-PCMS

Device

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-rest

Device

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.

Primary outcomes

  1. Transcranial magnetic stimulation to evaluate corticospinal transmission

    Time frame: 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 outcomes

  1. Voluntary force production to evaluate motor performance

    Time frame: 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.

  2. Maximum finger excursions to evaluate motor performance

    Time frame: 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.

  3. Maximum finger spread to evaluate motor performance

    Time frame: 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.

  4. Box and Block Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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