Brief Summary

Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone. Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.

Trial Health

100

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline

Completed

Started Dec 2015

Typical duration for not_applicable healthy

Status

completed

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

2 years study duration

First Submitted

Initial submission to the registry

November 25, 2015

Completed

6 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

November 25, 2015

Last Update Submit

October 30, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

Change from baseline peak-to-peak amplitude of motor evoked potential
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The peak-to-peak amplitude of the EMG response will be measured.
Immediately before and within 60 minutes following intervention
Change from baseline resting motor threshold
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The lowest stimulator output needed to elicit a consistent response will be recorded.
Immediately before and within 60 minutes following intervention

Study Arms (7)

Primed PAS 1A

EXPERIMENTAL

Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).