- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565199
Premotor Cortex: A New Target for Stroke Motor Rehabilitation
August 14, 2023 updated by: Cathrin Buetefisch, Emory University
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.
Study Overview
Status
Suspended
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cathrin Buetefisch, MD, PhD
- Phone Number: 404-712-5507
- Email: cathrin.buetefisch@emory.edu
Study Contact Backup
- Name: Farrah E Rink, MHSc
- Email: farrah.rink@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Motor training only (pilot participants):
- Have the ability to give informed, written consent
- Be aged 18-80 years old
- Be right-handed using the Edinburgh handedness inventory
- Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
- No current depression (score less than 7 on the Hamilton Depression Rating Scale (HDRS))
- No neurological disease
- No contradictions to Transcranial Magnetic Stimulation (TMS)
- TMS over the extensor carpi ulnaris (ECU) hotspot must evoke a motor evoked potential (MEP) in the ECU muscle
- MEP amplitude must increase by at least 20% as the TMS intensity increases
- The subjects must be comfortable when receiving TMS of all strengths.
Remaining study participants:
- 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 (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
- No current depression (score less than a 7 on the Hamilton Depression Rating Scale (HDRS))
- No neurological disease
- 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
- The subjects must be comfortable when receiving TMS of all strengths.
Exclusion Criteria:
- Impaired cognitive abilities (score lesser than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
- Current depression (score 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single motor training only
For a pilot experiment, healthy, right-handed subjects will complete one testing session.
During the testing session, subjects will complete motor training.
The results of this experiment will determine the motor training protocol used in the main experiment.
|
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.
|
Experimental: Repetitive TMS during motor training
Healthy, right-handed subjects will complete five testing sessions.
During each testing session, subjects will complete motor training while receiving one of five repetitive transcranial magnetic stimulation (rTMS) protocols.
Subjects will receive a different rTMS protocol at each testing session.
By the end of the study, each subject will have received all rTMS protocols.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wrist acceleration
Time Frame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
The subjects will be asked to perform 7 isometric wrist extensions before and after motor training.
Wrist acceleration will be measured by a gyroscope taped to the dorsum of the subject's hand undergoing motor training.
An increase in the maximum acceleration that persists at least an hour after training is indicative of motor learning.
We will compare the effect of the rTMS protocols on the change in the wrist acceleration associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).
|
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Change in stimulus response curve (SRC)
Time Frame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
The stimulus response curve (SRC) is a set of motor evoked potentials (MEPs) collected in response to transcranial magnetic stimulation (TMS) pulses of increasing intensities.
The SRC can characterize input-output parameters of the corticospinal tract and organization of the primary motor cortex.
A change in the SRC parameters after training will reflect a change in the organization of the primary motor cortex associated with motor learning.
We will compare the effect of the rTMS protocols on the change in the SRC parameters associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).
|
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Change in short interval intracortical inhibition (SICI)
Time Frame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
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 (ms).
The amplitude of a conditioned TS-evoked MEP will be expressed as a percent of the amplitude of an unconditioned TS-evoked MEP.
A decrease in the percent MEP after training would indicate a increase in SICI.
An increase in the percent MEP after training would indicate a decrease in SICI.
We will compare the effect of the rTMS protocols on the change in SICI associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).
|
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wrist force
Time Frame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
The subjects will be asked to perform 7 isometric wrist extensions before and after motor training.
A force transducer transducer will record the maximum force produced during the wrist extensions.
|
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Change in reaction time
Time Frame: Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training.
Electomyographic (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 (ECU) muscle.
|
Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
|
Change in task accuracy
Time Frame: Baseline and post-motor training (1 minute after completion of motor training)
|
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.
|
Baseline and post-motor training (1 minute after completion of motor training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
September 29, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimated)
October 1, 2015
Study Record Updates
Last Update Posted (Actual)
August 16, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00081901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Motor Training
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
University of California, San DiegoCompletedAutism Spectrum Disorder | Autistic DisorderUnited States
-
University of PlymouthRecruiting
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtCompleted
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanNot yet recruitingChronic StrokeTaiwan
-
Riphah International UniversityRecruiting
-
National Cheng-Kung University HospitalRecruitingWriting Learning DisabilityTaiwan
-
National Cheng-Kung University HospitalNot yet recruitingDevelopmental Delay | Preterm Children
-
Izmir Katip Celebi UniversityCompleted