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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Motor Training
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.
Other: Motor Training
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.
Device: rTMS over Premotor Cortex (Contralateral Hemisphere)
  • Location of rTMS: premotor cortex
  • Frequency of rTMS: 0.1 Hz
  • Time of rTMS: 50 milliseconds before the onset of movement-related EMG
  • Device: MagStim Super Rapid 2 Transcranial Magnetic Stimulator
Device: rTMS over Premotor Cortex (Ipsilateral Hemisphere)
  • Location of rTMS: premotor cortex
  • Frequency of rTMS: 0.1 Hz
  • Time of rTMS: 50 milliseconds before the onset of movement-related EMG
  • Device: Super Rapid 2 Transcranial Magnetic Stimulator
Device: rTMS (Control 1)
  • Location of rTMS: premotor cortex
  • Frequency of rTMS: 0.1 Hz
  • Time of rTMS: 400 milliseconds after the onset of movement-related EMG
  • Device: Super Rapid 2 Transcranial Magnetic Stimulator
Device: rTMS (Control 2)
  • Location of rTMS: somatosensory cortex
  • Frequency of rTMS: 0.1 Hz
  • Time of rTMS: 50 milliseconds before the onset of movement-related EMG
  • Device: Super Rapid 2 Transcranial Magnetic Stimulator
Device: rTMS (Control 3)
  • Location of rTMS: premotor cortex
  • Frequency of rTMS: 0.1 Hz
  • Time of rTMS: 50 milliseconds before the onset of movement-related EMG
  • Device: Super Rapid 2 Transcranial Magnetic Stimulator with Sham Coil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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