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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Non-invasive Brain Stimulation ModalitiesExperimental treatment 1 intervention

Trial outcomes

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.

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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