StrokeNCT02565199
Premotor Cortex: A New Target for Stroke Motor Rehabilitation
A study testing rTMS Over Contralateral Hemisphere of Premotor Cortex and rTMS Over Ipsilateral Hemisphere of Premotor Cortex in people with Stroke, run by Emory University at 1 site in United States.
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 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- rTMS Over Contralateral Hemisphere of Premotor Cortex and rTMS Over Ipsilateral Hemisphere of Premotor Cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2016to 10 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have the ability to give informed, written consent
- Be aged 55-80 years old
- Be right-handed using the Edinburgh handedness inventory
- Have intact cognitive abilities, determined by a score higher than the 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- No current depression, determined by a score less than a 7 on the Hamilton Depression Rating Scale (HDRS)
- No neurological disease
Show all 10Show fewer
- No contradictions to Transcranial Magnetic Stimulation (TMS)
- TMS over the extensor carpi ulnaris (ECU) hotspot must be able to evoke a motor evoked potential (MEP) in the ECU muscle
- MEP amplitude must increase by at least 20% as the TMS intensity increases
- Comfortable when receiving TMS of all strengths
Who cannot join
- Impaired cognitive abilities, determined by a score less than the 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Current depression, determined by a score of more than 7 on the Hamilton Depression Rating Scale (HDRS)
- Neurological disease
- Has a contradiction to TMS
- MEP cannot be evoked with TMS in the ECU muscle
- Inability to tolerate one or more TMS strengths
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation
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. Consequently, the majority of the 6.8 million people who have suffered a stroke in the United States experience hemiparesis as a result of the infarct. Although stroke survivors are encouraged to participate in rehabilitation programs, 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, stroke 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. Healthy adults made larger training-related improvements in their motor performance when they received rTMS over the primary motor cortex during motor training. 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 healthy adults.
In this study the researchers will evaluate the effect of premotor cortex (PMC) rTMS on motor learning with a double-blind randomized study consisting of five experiments separated by at least 72 hours. During each experiment, participants complete motor training while receiving one of five rTMS protocols. All participants will receive each rTMS protocol once. The order of the rTMS protocols will be randomized and counterbalanced prior to recruitment. The researchers will evaluate the effect of each rTMS protocol on training-related motor learning by collecting kinematic and neurophysiological measurements before (pre-training), immediately post-training, and 60 minutes post-training.
- Conditions
- Stroke
- Being tested
- rTMS Over Contralateral Hemisphere of Premotor Cortex, rTMS Over Ipsilateral Hemisphere of Premotor Cortex, Control 1: rTMS Timed 400 ms After Movement-related EMG, Control 2: rTMS Over the Somatosensory Cortex, Control 3: Sham rTMS
- Keywords
- Transcranial Magnetic Stimulation, Hemiparesis, Post-stroke rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS Over Contralateral Hemisphere of Premotor CortexDevice
Also called MagStim Super Rapid 2 Transcranial Magnetic Stimulator
This intervention uses rTMS located over the premotor cortex of the contralateral hemisphere (opposite side of the body) to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related electromyography (EMG). The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used.
rTMS Over Ipsilateral Hemisphere of Premotor CortexDevice
Also called MagStim Super Rapid 2 Transcranial Magnetic Stimulator
This intervention uses rTMS located over the premotor cortex of the ipsilateral hemisphere (the same side of the body) to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used.
Control 1: rTMS Timed 400 ms After Movement-related EMGDevice
Also called MagStim Super Rapid 2 Transcranial Magnetic Stimulator
Control condition 1 uses rTMS over the premotor cortex of the contralateral hemisphere to the training wrist, with a frequency of 0.1 Hz. The rTMS occurs 400 milliseconds (ms) after the onset of movement-related EMG and uses the MagStim Super Rapid 2 Transcranial Magnetic Stimulator.
Control 2: rTMS Over the Somatosensory CortexDevice
Also called MagStim Super Rapid 2 Transcranial Magnetic Stimulator
This intervention uses rTMS located over the somatosensory cortex of the contralateral hemisphere to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used.
Control 3: Sham rTMSDevice
Also called MagStim Super Rapid 2 Transcranial Magnetic Stimulator with Sham Coil
Control condition 3 uses rTMS located over the premotor cortex of the contralateral hemisphere to the training wrist, at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator with the sham coil is used.
Motor TrainingOther
During motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive TMS During Motor Training | Experimental | Healthy, right-handed participants complete five testing sessions. During each testing session, participants complete motor training while receiving one of five repetitive transcranial magnetic stimulation (rTMS) protocols. Participants receive a different rTMS protocol at each testing session so that they receive all rTMS protocols by the end of the study. Receives: Device: rTMS Over Contralateral Hemisphere of Premotor Cortex; Device: rTMS Over Ipsilateral Hemisphere of Premotor Cortex; Device: Control 1: rTMS Timed 400 ms After Movement-related EMG; Device: Control 2: rTMS Over the Somatosensory Cortex; Device: Control 3: Sham rTMS; Other: Motor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve (SRC)
Functional organization of ipsilateral M1 is assessed by changes in area under the curve of stimulus response curves over the hotspots of an agonist (extensor carpi ulnaris (ECU)) muscle of the training movement. The area under the curve (AUC) was calculated by summing the mean motor evoked potential (MEP) amplitudes per intensity and subject evoked by TMS at intensities 25 -80% maximum stimulator output (MSO), in increments of 5% MSO. The area under the stimulus response curve is normalized to the pre-training measurement.
Measured: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Secondary outcomes (2)
Change in Mean Reaction Time
Participants are asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electromyographic (EMG) activity recorded during the ballistic wrist extensions is 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 (ECU) muscle. The change in reaction time from baseline is calculated as the post-training score minus the baseline score.
Measured: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Change in Mean Peak Velocity
Peak velocity of wrist movement from 6 auditory-paced ballistic wrist extension was collected using a gyrometer. Peak velocity is an assessment of hand motor kinematics. Velocity measures speed in a particular direction of motion.
Measured: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start7 Jul 2016
- Primary completion10 Nov 2019
- Study completion10 Nov 2019
Why it stopped: Study was suspended pending additional funding to continue participant recruitment and was ultimately terminated in 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized to the order in which they receive the five rTMS protocols.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Cathrin Buetefisch, Emory University
- Investigators
- Cathrin Buetefisch, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565199
- Sponsor's protocol ID
- IRB00081901
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2015
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT02565199
- Acronym / sponsor ID
- IRB00081901
- Conditions
- Stroke
- Keywords
- Transcranial Magnetic Stimulation, Hemiparesis, Post-stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was suspended pending additional funding to continue participant recruitment and was ultimately terminated in 2024.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 27 Oct 2026
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. Consequently, the majority of the 6.8 million people who have suffered a stroke in the United States experience hemiparesis as a result of the infarct. Although stroke survivors are encouraged to participate in rehabilitation programs, 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, stroke 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. Healthy adults made larger training-related improvements in their motor performance when they received rTMS over the primary motor cortex during motor training. 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 healthy adults.
In this study the researchers will evaluate the effect of premotor cortex (PMC) rTMS on motor learning with a double-blind randomized study consisting of five experiments separated by at least 72 hours. During each experiment, participants complete motor training while receiving one of five rTMS protocols. All participants will receive each rTMS protocol once. The order of the rTMS protocols will be randomized and counterbalanced prior to recruitment. The researchers will evaluate the effect of each rTMS protocol on training-related motor learning by collecting kinematic and neurophysiological measurements before (pre-training), immediately post-training, and 60 minutes post-training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
- Model description
- Participants are randomized to the order in which they receive the five rTMS protocols.
| Arm | Type | Receives |
|---|---|---|
| Repetitive TMS During Motor Training | Experimental | Device: rTMS Over Contralateral Hemisphere of Premotor Cortex, Device: rTMS Over Ipsilateral Hemisphere of Premotor Cortex, Device: Control 1: rTMS Timed 400 ms After Movement-related EMG, Device: Control 2: rTMS Over the Somatosensory Cortex, Device: Control 3: Sham rTMS, Other: Motor TrainingHealthy, right-handed participants complete five testing sessions. During each testing session, participants complete motor training while receiving one of five repetitive transcranial magnetic stimulation (rTMS) protocols. Participants receive a different rTMS protocol at each testing session so that they receive all rTMS protocols by the end of the study. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have the ability to give informed, written consent
- Be aged 55-80 years old
- Be right-handed using the Edinburgh handedness inventory
- Have intact cognitive abilities, determined by a score higher than the 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- No current depression, determined by a score less than a 7 on the Hamilton Depression Rating Scale (HDRS)
Key exclusion criteria (6 listed)
- Impaired cognitive abilities, determined by a score less than the 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Current depression, determined by a score of more than 7 on the Hamilton Depression Rating Scale (HDRS)
- Neurological disease
- Has a contradiction to TMS
- MEP cannot be evoked with TMS in the ECU muscle
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 |
|---|---|---|
| rTMS Over Contralateral Hemisphere of Premotor CortexAlso: MagStim Super Rapid 2 Transcranial Magnetic StimulatorThis intervention uses rTMS located over the premotor cortex of the contralateral hemisphere (opposite side of the body) to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related electromyography (EMG). The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used. | Device | Repetitive TMS During Motor Training |
| rTMS Over Ipsilateral Hemisphere of Premotor CortexAlso: MagStim Super Rapid 2 Transcranial Magnetic StimulatorThis intervention uses rTMS located over the premotor cortex of the ipsilateral hemisphere (the same side of the body) to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used. | Device | Repetitive TMS During Motor Training |
| Control 1: rTMS Timed 400 ms After Movement-related EMGAlso: MagStim Super Rapid 2 Transcranial Magnetic StimulatorControl condition 1 uses rTMS over the premotor cortex of the contralateral hemisphere to the training wrist, with a frequency of 0.1 Hz. The rTMS occurs 400 milliseconds (ms) after the onset of movement-related EMG and uses the MagStim Super Rapid 2 Transcranial Magnetic Stimulator. | Device | Repetitive TMS During Motor Training |
| Control 2: rTMS Over the Somatosensory CortexAlso: MagStim Super Rapid 2 Transcranial Magnetic StimulatorThis intervention uses rTMS located over the somatosensory cortex of the contralateral hemisphere to the training wrist. For this intervention the rTMS occurs at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator is used. | Device | Repetitive TMS During Motor Training |
| Control 3: Sham rTMSAlso: MagStim Super Rapid 2 Transcranial Magnetic Stimulator with Sham CoilControl condition 3 uses rTMS located over the premotor cortex of the contralateral hemisphere to the training wrist, at a frequency of 0.1 Hz, 50 milliseconds (ms) before the onset of movement-related EMG. The MagStim Super Rapid 2 Transcranial Magnetic Stimulator with the sham coil is used. | Device | Repetitive TMS During Motor Training |
| Motor TrainingDuring motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue. | Other | Repetitive TMS During Motor Training |
Primary outcome
Change in Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve (SRC)
Time frame: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Functional organization of ipsilateral M1 is assessed by changes in area under the curve of stimulus response curves over the hotspots of an agonist (extensor carpi ulnaris (ECU)) muscle of the training movement. The area under the curve (AUC) was calculated by summing the mean motor evoked potential (MEP) amplitudes per intensity and subject evoked by TMS at intensities 25 -80% maximum stimulator output (MSO), in increments of 5% MSO. The area under the stimulus response curve is normalized to the pre-training measurement.
2 secondary outcomes
Change in Mean Reaction Time
Time frame: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Change in Mean Peak Velocity
Time frame: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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, PhD principal investigator
Emory 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 rTMS Over Contralateral Hemisphere of Premotor Cortex and rTMS Over Ipsilateral Hemisphere of Premotor Cortex in people with Stroke, run by Emory 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Oct 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?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve (SRC) (time frame: Baseline/Pre-training, Immediately Post-training, 60 Minutes Post-training during each of 5 study visits (up to 217 days)). 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 27 Oct 2026.