Recruiting

rTMS

Sponsor:

Duke University

Code:

NCT06765642

Conditions

Stroke

Stroke Patients

Arm Weakness as a Consequence of Stroke

Brain Stimulation

Transcranial Magnetic Stimulation Repetitive

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief summary:

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.

Conditions

Stroke

Stroke Patients

Arm Weakness as a Consequence of Stroke

Brain Stimulation

Transcranial Magnetic Stimulation Repetitive

Study ID

NCT06765642

Start date

Jun 9, 2025

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion criteria:

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

Exclusion criteria

1. Bilateral strokes (infarcts and/or hematoma)
2. Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
3. 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.
4. 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).
5. Presence of any MRI/rTMS risk factors including but not limited to:

1. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
2. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
3. history of seizure disorder before stroke or seizure after stroke.
4. preexisting scalp lesion or bone defect or hemicraniectomy.
6. Concurrent enrollment in another interventional stroke recovery study.
7. Concerns that the subject cannot comply with study procedures and visits.
8. Pregnant individuals

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-invasive Brain Stimulation Modalities

All participants will undergo three non-invasive brain stimulation modalities:

1. Focal conventional iTBS over the ipsilesional motor cortex (i.e., a single bout of 600 pulses over a single spot; FiTBS600).
2. Focal high dose iTBS over the ipsilesional motor cortex (i.e. 4 bouts of 600 pulses over a single spot = 2400 pulses; FiTBS2400).
3. Diffuse high dose iTBS over the ipsilesional motor cortex (i.e. 4 bouts of 600 pulses over 4 spots: 600 pulses/spot × 4 spots = 2400 pulses; DiTBS2400)

Interventions

Transcranial Magnetic Stimulation

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • stroke
  • arm weakness
  • arm weakness as a consequence of stroke
  • stroke patients
  • transcranial magnetic stimulation
  • transcranial magnetic stimulation repetitive
  • motor learning
  • chronic stroke
  • chronic stroke patients
  • chronic stroke survivors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-22.