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StrokeNCT07860073

Optimizing Cortical Priming

A study testing 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) and 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1) in people with Stroke and Hemiparesis After Stroke, run by Wan-Wen Liao 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

Each year over 795,000 people suffer from stroke resulting in the primary cause of adult disability. Persistent upper limb dysfunction due to stroke significantly impairs performance and results in a serious decline of quality of life. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke, Hemiparesis After Stroke
What is being tested?
5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) and 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Apr 2016to May 2018
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Stroke Participants:
  • Age 50 years and older
  • Unilateral ischemic cortical or white matter subcortical stroke
  • At least 6 months post-stroke and have completed all inpatient and outpatient therapy
  • Residual arm paresis as indicated by Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores between 25 and 65 (individuals in this range have demonstrated the ability to generate motor evoked potentials during active muscle contraction)
  • Able to reach forward for at least 15 centimeters
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  • Healthy Controls:
  • Age-matched to a stroke participant within plus or minus 3 years
  • Gender-matched to a stroke participant

Who cannot join

  • Stroke Participants and Healthy Controls:
  • A non-stroke neuromuscular disorder restricting exercise
  • Stroke involving the brainstem or cerebellum
  • Any medical conditions that could limit physical activity levels required for testing and training, such as acute cardiac or pulmonary/respiratory conditions, or uncontrolled hypertension (blood pressure greater than 180/100 mmHg)
  • Significant orthopedic or chronic pain conditions limiting upper extremity movements
  • Any medications that may adversely impact upper extremity control
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  • Metallic implant in the head or chest, implanted pumps/stimulators/shunts, or cardiac pacemaker
  • A history of seizures
  • Use of any neuropsychoactive medication
  • History of fainting spells of undetermined etiology
  • Pregnancy
  • Any other concomitant neurological condition affecting sensorimotor systems, such as brain tumor, substance abuse, or dementia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Physical Therapy & Rehabilitation Science, University of Maryland Baltimore

    Baltimore, Maryland

Other trials in United States

About this study

Official title: Optimizing Cortical Priming to Enhance Bimanual Arm Coordination in Individuals With Chronic Stroke

Each year over 795,000 people suffer from stroke resulting in the primary cause of adult disability. Persistent upper limb dysfunction due to stroke significantly impairs performance and results in a serious decline of quality of life. As most daily activities involve the use of both arms, restoring the coordination between upper limbs is essential for regaining functional independence. Only a few interventions have been designed for improving function of both arms, and most of these interventions have focused on movement retraining without directly facilitating the injured brain. The purpose of this study is to design and test a noninvasive brain stimulation protocol tailored to enhance the coordination between the arms in individuals with chronic stroke. The investigators propose that the dorsal premotor cortex on the noninjured side of the brain (cPMd) could serve as a potential stimulation target for enhancing arm coordination and brain function. In the first part of this study (Aim 1), the investigators will examine its effects on modulating arm movements in individuals with chronic stroke. In the second part of this study (Aim 2), the investigators will upregulate the activity of the most responsive region (cPMd or iM1) of each participant prior to arm movement training (bilateral arm training, BAT) to determine the combined effects on augmenting bilateral arm coordination and brain function in individuals with chronic stroke.

Being tested
5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd), 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1)
Medical subject headings
Stroke

What participants receive

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

  • 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd)Device

    Participant received 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) only (Aim 1) and 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) combined with 3 essions of bilateral arm training (Aim 2)

  • 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1)Device

    Participant received 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) only (Aim 1) and 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) combined with 3 essions of bilateral arm training (Aim 2)

Study groups in NCT07860073
Study groupRoleWhat they receive
5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Contralesional Dorsal Premotor CortexExperimentalParticipants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the contralesional dorsal premotor cortex (cPMd) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of 5 Hz cPMd rTMS only. In Aim 2, participants who were responsive to cPMd stimulation received 5 Hz cPMd rTMS immediately prior to bilateral arm training (BAT) for 3 sessions.
Receives: Device: 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd)
5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Ipsilesional Primary Motor CortexExperimentalParticipants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the ipsilesional primary motor cortex (iM1) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of iM1 rTMS only. In Aim 2, participants who were responsive to iM1 stimulation received iM1 rTMS immediately prior to bilateral arm training (BAT) for 3 sessions.
Receives: Device: 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1)

What is being measured

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

  1. Cortical Excitability Assessed by Transcranial Magnetic Stimulation (TMS)-Induced Motor Evoked Potential (MEP) Amplitude

    Cortical excitability was quantified using single-pulse Transcranial Magnetic Stimulation (TMS) over the targeted motor cortex. Peak-to-peak amplitude of Motor Evoked Potentials (MEPs) recorded from the target upper limb muscle via surface electromyography (EMG) was measured in microvolts to evaluate stimulation- and training-induced neuroplastic changes.

    Measured: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

  2. Interlimb Coordination Assessed by Surface Electromyography (EMG) -Interlimb Muscle Coherence

    Interlimb coordination was quantified by measuring interlimb muscle coherence (intermuscular coherence) between homologous upper limb muscles via surface electromyography (EMG) during bilateral arm movements. Coherence was calculated in the frequency domain, where higher values indicated greater synchronous neural drive and coordination between the two upper limbs.

    Measured: Day 1: Baseline and within 30 minutes post-stimulation (Aim 1)

  3. Arm Reaching Kinematics (Speed, Acceleration, Interlimb Coordination, and Trajectory Smoothness) Assessed by the 3D Kinesiological Instrument for Normal and Altered Reaching Movement (KINARM)

    Upper limb kinematic performance during arm reaching tasks was assessed using the 3D Kinesiological Instrument (KINARM). Specific kinematic parameters analyzed included: (1) movement speed, (2) movement acceleration, (3) interlimb coordination, and (4) arm trajectory smoothness.

    Measured: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training) (Aim 2)

Secondary outcomes (3)

  1. Intracortical Inhibition Assessed by Paired-Pulse Transcranial Magnetic Stimulation (TMS)- Short-Interval Intracortical Inhibition (SICI)

    Intracortical inhibition was quantified using paired-pulse Transcranial Magnetic Stimulation (TMS) over the motor cortex, recorded via surface electromyography (EMG) from the target upper limb muscle. A subthreshold conditioning stimulus followed by a suprathreshold test stimulus was applied. Intracortical inhibition was expressed as the ratio or percentage of the conditioned Motor Evoked Potential (MEP) amplitude relative to the unconditioned test MEP amplitude (% of test MEP), where lower percentages indicated greater intracortical inhibition.

    Measured: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

  2. Interhemispheric Inhibition Assessed by Transcranial Magnetic Stimulation (TMS) Ipsilateral Silent Period (iSP)

    Interhemispheric inhibition was quantified by the Ipsilateral Silent Period (iSP), elicited by delivering single-pulse Transcranial Magnetic Stimulation (TMS) to the motor cortex ipsilateral to the target upper limb during voluntary isometric muscle contraction. The iSP was recorded via surface electromyography (EMG) and quantified by duration in milliseconds (ms) and normalized area of EMG suppression (%).

    Measured: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

  3. Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)

    The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a performance-based impairment index used to assess upper limb motor recovery in individuals with post-stroke hemiparesis. The upper extremity motor domain consists of 33 items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), yielding a total motor score ranging from 0 to 66, where higher scores indicate better upper extremity motor function (less motor impairment).

    Measured: Aim 1: Day 1 (Baseline); Aim 2: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training)

Timeline

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

  1. First posted6 Oct 2026
  2. Study startApr 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

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
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860073
Sponsor's protocol ID
HP00068268
Status last verified
Oct 2026
First submitted
4 Feb 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: To protect the privacy of stroke participants and adhere to the Institutional Review Board (IRB) guidelines, individual participant data (IPD) will not be made publicly available. The raw neurophysiological data and clinical assessments are reserved for the research team to complete the primary and secondary analyses specified in the study protocol. However, de-identified aggregate results and study documents will be shared through peer-reviewed publications. Some participant data were shared on one of our publications (https://doi.org/10.1016/j.clinph.2019.04.711)

Questions about this trial

What is this clinical trial studying?

A study testing 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) and 5 Hz Repetitive transcranial magnetic stimulation (rTMS) on the ipsilesional primary motor cortex (iM1) in people with Stroke and Hemiparesis After Stroke, run by Wan-Wen Liao 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 9 inclusion and 12 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 6 Oct 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?

Cortical Excitability Assessed by Transcranial Magnetic Stimulation (TMS)-Induced Motor Evoked Potential (MEP) Amplitude (time frame: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07860073.

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 6 Oct 2026.

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Optimizing Cortical Priming (NCT07860073) | AzTrials