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NCT Number: NCT06765642

The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.

The study is about using a brain stimulation technique called rTMS (Repetitive Transcranial Magnetic Stimulation) to help improve hand muscles in people who had a stroke. Researchers want to understand how this device can help stroke patients use their hands better.

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Key information

About this study

The goal of this study is to determine the efficacy of a high-dose of a excitatory-specific patterned Transcranial Magnetic Stimulation (i.e., intermittent theta-burst stimulation - iTBS) protocol as a neuromodulatory tool on the neuromotor recovery (corticospinal excitability and motor performance) in individuals with chronic stroke using either the conventional iTBS protocol (600 pulses; iTBS600) or a high dose iTBS protocols (a total of 2400 pulses) over a single spot (Focal iTBS; FiTBS2400) and 4 spots (Diffuse iTBS: DiTBS2400) on the ipsilesional hemisphere. The use of this approach aims to potentially maximize motor recovery in chronic stroke by harnessing corticospinal plasticity and modulating motor learning behavior.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >=21 years old of any race or gender
  • First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset
  • Unilateral arm weakness measured by FM-UM scale <= 62 out of 66
  • Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject

Exclusion criteria

  • Bilateral strokes (infarcts and/or hematoma)
  • Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
  • History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study.
  • Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later).
  • Presence of any MRI/rTMS risk factors including but not limited to:
  • an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
  • a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
  • history of seizure disorder before stroke or seizure after stroke.
  • preexisting scalp lesion or bone defect or hemicraniectomy.
  • Concurrent enrollment in another interventional stroke recovery study.
  • Concerns that the subject cannot comply with study procedures and visits.
  • Pregnant individuals

Treatment and study plan

Transcranial magnetic stimulation

Diagnostic Test

The use of this approach aims to potentially maximize motor recovery in chronic stroke by harnessing corticospinal plasticity and modulating motor learning behavior.

Other names: Repetitive Transcranial Magnetic Stimulation

Primary outcomes

  1. To determine whether there is overall stimulation effect among three stimulation paradigms (FiTBS600; FiTBS2400; DiTBS2400) on the ipsilesional corticospinal excitability of a hand muscle.

    Time frame: Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart)

    Each intervention session (total of 3) will consist of one format of iTBS stimulation. Before and after the intervention, single pulse TMS (spTMS) and motor sequence learning (MSL) will be used to assess the effect of the intervention on corticospinal excitability and motor performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan N Gonzalez, MS

CONTACT

[email protected]

9196687597

Wuwei Feng, MD

CONTACT

[email protected]

919 681 1700

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients

Acronym: REALISE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2025
Registry last updated
May 22, 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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