StrokeNCT03268070
Transcranial Magnetic Stimulation in Stroke Motor Rehabilitation Treatment
A study testing Repetitive TMS over contralateral premotor cortex., Repetitive TMS over ipsilateral premotor cortex. and Repetitive TMS over contralateral primary motor cortex. in people with Stroke, run by Emory University.
Trial summary
The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Repetitive TMS over contralateral premotor cortex., Repetitive TMS over ipsilateral premotor cortex. and Repetitive TMS over contralateral primary motor cortex.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to give informed, written consent
- Be aged 30-80 years old
- Have a single ischemic infarction affecting the primary motor system
- Have intact cognitive abilities
- No current depression
- No neurological disease
Show all 12Show fewer
- No contradictions to TMS
- No history of seizures or epilepsy
- No implanted medical device
- No metal in neck or head
- No history of migraine headaches
- No intake of medication that lowers seizure threshold
Who cannot join
- none
About this study
Official title: Targeting Motor Areas for Customized Transcranial Magnetic Stimulation in Motor Rehabilitation Treatment of Chronic Stroke Patients
The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.
Read the detailed description
Occlusion of the middle cerebral artery is the most common cause of stroke. Because the middle cerebral artery supplies blood to the motor cortices, middle cerebral artery stroke often impacts the integrity of the motor cortex and its associated corticospinal projections. Less than half of all individuals post-stroke regain complete motor function. Because motor deficits, especially of the upper extremities, can dampen the quality of life, there is an urgent need to improve current rehabilitation programs to allow more stroke survivors to achieve higher functional gains.
Motor training is an important part of recovery after stroke. During motor training, patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in adults who experienced a stroke more than 6 months ago.
- Conditions
- Stroke
- Being tested
- Repetitive TMS over contralateral premotor cortex., Repetitive TMS over ipsilateral premotor cortex., Repetitive TMS over contralateral primary motor cortex., Sham Repetitive TMS over contralateral premotor cortex., Single TMS over extensor carpi ulnaris spot of motor cortex
- Keywords
- Transcranial Magnetic Stimulation, Neurophysiology, Neuroscience, Stroke Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive TMS over contralateral premotor cortex.Device
Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
Repetitive TMS over ipsilateral premotor cortex.Device
Repetitive Transcranial magnetic stimulation (rTMS) will be applied over ipsilateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
Repetitive TMS over contralateral primary motor cortex.Device
Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral primary motor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain.Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
Sham Repetitive TMS over contralateral premotor cortex.Device
Sham rTMS will be applied over contralateral premotor cortex. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
Single TMS over extensor carpi ulnaris spot of motor cortexDevice
Single-pulse TMS will be applied over the extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1) during motor training.TMS uses magnetism to excite neurons near the surface of the brain. TMS pulses will be applied at different strengths (30%-80% maximum stimulator output) and record subsequent activity of the ECU muscle using electromyography (EMG).
| Study group | Role | What they receive |
|---|---|---|
| Repetitive TMS over contralateral premotor cortex | Experimental | Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex. Receives: Device: Repetitive TMS over contralateral premotor cortex. |
| Repetitive TMS over ipsilateral premotor cortex | Experimental | Location of repetitive Transcranial Magnetic Stimulation (rTMS): ipsilateral premotor cortex. Receives: Device: Repetitive TMS over ipsilateral premotor cortex. |
| Repetitive TMS over contralateral primary motor cortex | Experimental | Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral primary motor cortex. Receives: Device: Repetitive TMS over contralateral primary motor cortex. |
| Sham repetitive TMS over contralateral premotor cortex | Sham comparator | Location of Sham repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex. Receives: Device: Sham Repetitive TMS over contralateral premotor cortex. |
| Single TMS over extensor carpi ulnaris spot of motor cortex | Experimental | Location of single-pulse Transcranial Magnetic Stimulation (sTMS): extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1). Receives: Device: Single TMS over extensor carpi ulnaris spot of motor cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wrist velocity
The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. Wrist velocity will be measured by a gyroscope taped to the dorsum of the wrist that was used during motor training. An increase in the maximum velocity that persists at least an hour after training is indicative of motor learning.
Measured: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in Stimulus Response Curve parameters
To measure organization of a motor region in the primary motor cortex supporting wrist movement, a Stimulus Response Curve (SRC) will be collected before and after motor training. SRC is a set of motor evoked potentials (MEP) that characterizes input-output parameters of the primary motor cortex and associated corticospinal tract. A change in the SRC parameters after training will reflect a change in the organization of the primary motor cortex.
Measured: Before, 0 mins after, 30 mins after and 60 mins after motor training.
Secondary outcomes (5)
Change in wrist force
The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. A force transducer will record the maximum force produced during the wrist extensions.
Measured: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in reaction time
Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electromyographic (EMG) activity recorded during the ballistic wrist extensions will be used to measure reaction time. Reaction time is the length of time between the auditory cue and the onset of the movement-related EMG burst of the extensor carpi ulnaris muscle.
Measured: Before, 0 mins after, 30 mins after and 60 mins after motor training.
Change in task accuracy
Task accuracy will be determined by the number of successful trials over the number of total trials. A trial will be considered successful when the subject moves a cursor from the home position into a target box by modulating the acceleration of their wrist. An increase in task accuracy after training will indicate motor learning.
Measured: During motor training (will compare first block to last block).
Change in Short interval intracortical inhibition (SICI) of the primary motor cortex
Short interval intracortical inhibition (SICI) is an inhibitory phenomenon in the motor cortex. To test for SICI, a sub-threshold conditioning stimulus (CS) will precede a supra-threshold test stimulus (TS) by 2 milliseconds. The amplitude of a conditioned TS-evoked MEP will be expressed as a percent of the amplitude of an unconditioned TS-evoked MEP (% MEP). A decrease in the % MEP after training would indicate a increase in SICI. An increase in the % MEP after training would indicate a decrease in SICI.
Measured: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in Resting Motor Threshold
Parametric Estimation by Sequential Testing (PEST) will be used to determine the Resting Motor Threshold (rMT). The mathematical algorithm implemented by PEST will determine the rMT with fewer TMS pulses than the traditional method.
Measured: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startMar 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: The study is withdrawn due to funding.
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 Emory 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathrin Buetefisch, Emory University
- Investigators
- Cathrin Buetefisch, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268070
- Sponsor's protocol ID
- IRB00097855
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2017
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data will be made available for sharing with other researchers. Data will be shared with the Enhancing Neuroimaging Genetics through Meta-Analysis (ENIGMA) Stroke Recovery group. The researchers plan to share the entire data set including clinical, behavioral, anatomical MRI data, with the ENIGMA Stroke Recovery group.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Motor Areas for Customized Transcranial Magnetic Stimulation in Motor Rehabilitation Treatment of Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT03268070
- Acronym / sponsor ID
- IRB00097855
- Conditions
- Stroke
- Keywords
- Transcranial Magnetic Stimulation, Neurophysiology, Neuroscience, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is withdrawn due to funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Aug 2017 (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 goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.
Detailed description
Occlusion of the middle cerebral artery is the most common cause of stroke. Because the middle cerebral artery supplies blood to the motor cortices, middle cerebral artery stroke often impacts the integrity of the motor cortex and its associated corticospinal projections. Less than half of all individuals post-stroke regain complete motor function. Because motor deficits, especially of the upper extremities, can dampen the quality of life, there is an urgent need to improve current rehabilitation programs to allow more stroke survivors to achieve higher functional gains.
Motor training is an important part of recovery after stroke. During motor training, patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in adults who experienced a stroke more than 6 months ago.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Repetitive TMS over contralateral premotor cortex | Experimental | Device: Repetitive TMS over contralateral premotor cortex.Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex. |
| Repetitive TMS over ipsilateral premotor cortex | Experimental | Device: Repetitive TMS over ipsilateral premotor cortex.Location of repetitive Transcranial Magnetic Stimulation (rTMS): ipsilateral premotor cortex. |
| Repetitive TMS over contralateral primary motor cortex | Experimental | Device: Repetitive TMS over contralateral primary motor cortex.Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral primary motor cortex. |
| Sham repetitive TMS over contralateral premotor cortex | Sham comparator | Device: Sham Repetitive TMS over contralateral premotor cortex.Location of Sham repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex. |
| Single TMS over extensor carpi ulnaris spot of motor cortex | Experimental | Device: Single TMS over extensor carpi ulnaris spot of motor cortexLocation of single-pulse Transcranial Magnetic Stimulation (sTMS): extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have the ability to give informed, written consent
- Be aged 30-80 years old
- Have a single ischemic infarction affecting the primary motor system
- Have intact cognitive abilities
- No current depression
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Repetitive TMS over contralateral premotor cortex.Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator. | Device | Repetitive TMS over contralateral premotor cortex |
| Repetitive TMS over ipsilateral premotor cortex.Repetitive Transcranial magnetic stimulation (rTMS) will be applied over ipsilateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator. | Device | Repetitive TMS over ipsilateral premotor cortex |
| Repetitive TMS over contralateral primary motor cortex.Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral primary motor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain.Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator. | Device | Repetitive TMS over contralateral primary motor cortex |
| Sham Repetitive TMS over contralateral premotor cortex.Sham rTMS will be applied over contralateral premotor cortex. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator. | Device | Sham repetitive TMS over contralateral premotor cortex |
| Single TMS over extensor carpi ulnaris spot of motor cortexSingle-pulse TMS will be applied over the extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1) during motor training.TMS uses magnetism to excite neurons near the surface of the brain. TMS pulses will be applied at different strengths (30%-80% maximum stimulator output) and record subsequent activity of the ECU muscle using electromyography (EMG). | Device | Single TMS over extensor carpi ulnaris spot of motor cortex |
Primary outcome
Change in wrist velocity
Time frame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. Wrist velocity will be measured by a gyroscope taped to the dorsum of the wrist that was used during motor training. An increase in the maximum velocity that persists at least an hour after training is indicative of motor learning.
Change in Stimulus Response Curve parameters
Time frame: Before, 0 mins after, 30 mins after and 60 mins after motor training.
To measure organization of a motor region in the primary motor cortex supporting wrist movement, a Stimulus Response Curve (SRC) will be collected before and after motor training. SRC is a set of motor evoked potentials (MEP) that characterizes input-output parameters of the primary motor cortex and associated corticospinal tract. A change in the SRC parameters after training will reflect a change in the organization of the primary motor cortex.
5 secondary outcomes
Change in wrist force
Time frame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in reaction time
Time frame: Before, 0 mins after, 30 mins after and 60 mins after motor training.
Change in task accuracy
Time frame: During motor training (will compare first block to last block).
Change in Short interval intracortical inhibition (SICI) of the primary motor cortex
Time frame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in Resting Motor Threshold
Time frame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available for sharing with other researchers. Data will be shared with the Enhancing Neuroimaging Genetics through Meta-Analysis (ENIGMA) Stroke Recovery group. The researchers plan to share the entire data set including clinical, behavioral, anatomical MRI data, with the ENIGMA Stroke Recovery group.
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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. This study is not recruiting at the moment.
Cathrin Buetefisch, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive TMS over contralateral premotor cortex., Repetitive TMS over ipsilateral premotor cortex. and Repetitive TMS over contralateral primary motor cortex. in people with Stroke, run by Emory University.
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 12 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wrist velocity (time frame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.). The study lists 2 primary outcomes in all. 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 28 Aug 2025.