Recruiting

REALISEHigh-Dose rTMS for Motor Recovery in Chronic Stroke

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What is being tested

Transcranial Magnetic Stimulation

Diagnostic Test
Who is being recruted

Brain Diseases+8

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorDuke University
Study ContactWuwei Feng, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 9, 2025

Actual date on which the first participant was enrolled.

This study explores a new approach to help individuals who have experienced a chronic stroke improve their movement abilities. It tests a therapy called Transcranial Magnetic Stimulation (TMS), which uses magnetic pulses to stimulate the brain. The study examines different doses of a specific type of TMS called intermittent theta-burst stimulation (iTBS) to see if it can enhance the brain's ability to change and recover, thereby improving motor skills. The participants in the study are people who have had a stroke and are experiencing long-term difficulties with movement. This research is important because it could lead to better recovery treatments for those living with the ongoing effects of a stroke. Participants in the study receive TMS treatment, which is delivered in two main ways: either as a conventional dose of 600 pulses or as a higher dose of 2400 pulses. The high-dose treatment is further divided into focusing on one specific area of the brain or spreading across four areas. The treatment aims to increase activity in the part of the brain that controls movement, which might help improve motor learning and performance. The study investigates how these different doses and methods affect the brain's excitability and the participants' ability to learn and perform motor tasks. The potential benefit is improved movement and recovery, though the study will carefully monitor for any risks associated with the higher doses of stimulation.

Official TitleEvaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients
NCT06765642
Principal SponsorDuke University
Study ContactWuwei Feng, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesNeurologic ManifestationsParesisSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesStroke

Criteria

Inclusion Criteria: 1. Age \>=21 years old of any race or gender 2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from stroke onset 3. Unilateral arm weakness measured by FM-UM scale \<= 62/64 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. History of confirmed dementia or taking the following dementia drugs, such as Donepezil, Rivastigmine, Galantamine, Memantine, Aducanumab, Lecanemab, Donanemab that affecting their ability to follow study procedure. 5. 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). 6. 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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Duke University Medical Center

Durham, United StatesOpen Duke University Medical Center in Google Maps
Recruiting
One Study Center