Study Stopped
The study is withdrawn due to funding.
Transcranial Magnetic Stimulation in Stroke Motor Rehabilitation Treatment
Targeting Motor Areas for Customized Transcranial Magnetic Stimulation in Motor Rehabilitation Treatment of Chronic Stroke Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
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Started Mar 2025
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
August 28, 2025
August 1, 2025
1.9 years
August 29, 2017
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Before, 0 mins after, 30 mins after and 60 mins after motor training.
Secondary Outcomes (5)
Change in wrist force
Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in reaction time
Before, 0 mins after, 30 mins after and 60 mins after motor training.
Change in task accuracy
During motor training (will compare first block to last block).
Change in Short interval intracortical inhibition (SICI) of the primary motor cortex
Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Change in Resting Motor Threshold
Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Study Arms (5)
Repetitive TMS over contralateral premotor cortex
EXPERIMENTALLocation of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex.
Repetitive TMS over ipsilateral premotor cortex
EXPERIMENTALLocation of repetitive Transcranial Magnetic Stimulation (rTMS): ipsilateral premotor cortex.
Repetitive TMS over contralateral primary motor cortex
EXPERIMENTALLocation of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral primary motor cortex.
Sham repetitive TMS over contralateral premotor cortex
SHAM COMPARATORLocation of Sham repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex.
Single TMS over extensor carpi ulnaris spot of motor cortex
EXPERIMENTALLocation of single-pulse Transcranial Magnetic Stimulation (sTMS): extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1).
Interventions
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 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 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 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-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).
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cathrin Buetefisch, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subjects will be blinded to the type of TMS that they receive on each day.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 29, 2017
First Posted
August 31, 2017
Study Start
March 1, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Individual participant data will be available for sharing following publication of primary results from this study, with no end date for sharing.
- Access Criteria
- The format of the shared data will be compatible with the ENIGMA data base. Outside researchers interested in using this data can contact Dr. Buetefisch at cathrin.buetefisch@emory.edu.
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.