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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Trial recruitment is currently suspended

Enrollment

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline

Completed

Started Sep 2015

Longer than P75 for not_applicable stroke

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.4 years study duration

Study Start

First participant enrolled

September 1, 2015

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed

Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

8.4 years

First QC Date

September 29, 2015

Last Update Submit

August 14, 2023

Conditions

Stroke

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

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).
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
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).
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
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).
Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)

Secondary Outcomes (3)

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)

Study Arms (2)

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.

Other: Motor Training

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.

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

Interventions

rTMS over Premotor Cortex (Contralateral Hemisphere)DEVICE

* 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