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Premotor Cortex: A New Target for Stroke Motor Rehabilitation

Primary Purpose

Stroke

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS over Premotor Cortex (Contralateral Hemisphere)
rTMS over Premotor Cortex (Ipsilateral Hemisphere)
rTMS (Control 1)
rTMS (Control 2)
rTMS (Control 3)
Motor Training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single motor training only

Repetitive TMS during motor training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in wrist acceleration
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).
Change in stimulus response curve (SRC)
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).
Change in short interval intracortical inhibition (SICI)
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).

Secondary Outcome Measures

Change in wrist force
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.
Change in reaction time
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.
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.

Full Information

First Posted
September 29, 2015
Last Updated
August 14, 2023
Sponsor
Emory University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT02565199
Brief Title
Premotor Cortex: A New Target for Stroke Motor Rehabilitation
Official Title
Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Study is temporarily suspended pending additional funding to continue subject recruitment.
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single motor training only
Arm Type
Experimental
Arm Description
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.
Arm Title
Repetitive TMS during motor training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS over Premotor Cortex (Contralateral Hemisphere)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS over Premotor Cortex (Ipsilateral Hemisphere)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS (Control 1)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS (Control 2)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS (Control 3)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Motor Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in wrist acceleration
Description
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).
Time Frame
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Title
Change in stimulus response curve (SRC)
Description
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).
Time Frame
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Title
Change in short interval intracortical inhibition (SICI)
Description
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).
Time Frame
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Secondary Outcome Measure Information:
Title
Change in wrist force
Description
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.
Time Frame
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Title
Change in reaction time
Description
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.
Time Frame
Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Title
Change in task accuracy
Description
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.
Time Frame
Baseline and post-motor training (1 minute after completion of motor training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Premotor Cortex: A New Target for Stroke Motor Rehabilitation

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