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Premotor Cortex: A New Target for Stroke Motor Rehabilitation

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ClinicalTrials.gov Identifier: NCT02565199
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE October 1, 2015
Last Update Posted Date June 12, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • 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).
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02565199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premotor Cortex: A New Target for Stroke Motor Rehabilitation
Official Title  ICMJE Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Motor Training
  • 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.
    Interventions:
    • Device: rTMS over Premotor Cortex (Contralateral Hemisphere)
    • Device: rTMS over Premotor Cortex (Ipsilateral Hemisphere)
    • Device: rTMS (Control 1)
    • Device: rTMS (Control 2)
    • Device: rTMS (Control 3)
    • Other: Motor Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cathrin Buetefisch, MD, PhD 404-712-5507 cathrin.buetefisch@emory.edu
Contact: Farrah E Rink, MHSc farrah.rink@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565199
Other Study ID Numbers  ICMJE IRB00081901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cathrin Buetefisch, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE American Heart Association
Investigators  ICMJE Not Provided
PRS Account Emory University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP