StrokeREALISENCT06765642
The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.
A study testing Transcranial Magnetic Stimulation in people with Stroke and Stroke Patients, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Stroke Patients, Arm Weakness as a Consequence of Stroke
- What is being tested?
- Transcranial Magnetic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Wayne Feng, MD, 919 681 1700, wayne.feng@duke.edu
About this study
Official title: Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in 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.
Read the detailed description
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.
- Conditions
- Stroke, Stroke Patients, Arm Weakness as a Consequence of Stroke, Brain Stimulation, Transcranial Magnetic Stimulation Repetitive, Transcranial Magnetic Stimulation
- Being tested
- Transcranial Magnetic Stimulation
- 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
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDiagnostic test
Also called Repetitive 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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Brain Stimulation Modalities | 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) Receives: Diagnostic Test: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start9 Jun 2025
- Primary completion13 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Feng, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765642
- Sponsor's protocol ID
- Pro00117160
- Acronym
- REALISE
- Status last verified
- May 2026
- First submitted
- 17 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients
- ClinicalTrials.gov ID
- NCT06765642
- Acronym / sponsor ID
- REALISE / Pro00117160
- Conditions
- Stroke, Stroke Patients, Arm Weakness as a Consequence of Stroke, Brain Stimulation, Transcranial Magnetic Stimulation Repetitive, Transcranial Magnetic Stimulation
- Keywords
- stroke, arm weakness, arm weakness as a consequence of stroke, stroke patients, transcranial magnetic stimulation, transcranial magnetic stimulation repetitive, motor learning, chronic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 13 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Brain Stimulation Modalities | Experimental | Diagnostic Test: Transcranial Magnetic StimulationAll 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Repetitive Transcranial Magnetic StimulationThe use of this approach aims to potentially maximize motor recovery in chronic stroke by harnessing corticospinal plasticity and modulating motor learning behavior. | Diagnostic test | Non-invasive Brain Stimulation Modalities |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wayne Feng, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Stroke and Stroke Patients, run by Duke University 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 4 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wuwei Feng, MD (919 681 1700, wayne.feng@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.