Skip to main content
Clinical Trials/NCT02565199
NCT02565199SuspendedNot Applicable

Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation

Emory University1 site in 1 country50 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Enrollment
50
Locations
1
Primary Endpoint
Change in stimulus response curve (SRC)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Single motor training only

Experimental

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: Motor Training (Other)

Repetitive TMS during motor training

Experimental

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: rTMS over Premotor Cortex (Contralateral Hemisphere) (Device)

Repetitive TMS during motor training

Experimental

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: rTMS over Premotor Cortex (Ipsilateral Hemisphere) (Device)

Repetitive TMS during motor training

Experimental

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: rTMS (Control 1) (Device)

Repetitive TMS during motor training

Experimental

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: rTMS (Control 2) (Device)

Repetitive TMS during motor training

Experimental

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: rTMS (Control 3) (Device)

Repetitive TMS during motor training

Experimental

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: Motor Training (Other)

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Change in wrist force(Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training))
  • Change in reaction time(Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training))
  • Change in task accuracy(Baseline and post-motor training (1 minute after completion of motor training))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cathrin Buetefisch

Associate Professor

Emory University

Study Sites (1)

Loading locations...

Similar Trials