Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation

October 30, 2019 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 and ≤ 30 years of age
  • Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
  • Elicitable N20 sensory evoked potential

Exclusion Criteria:

  • History of neurological disease
  • Seizure within the past 2 years
  • Currently taking epileptogenic medication
  • Peripheral neuropathy
  • Cognitive impairment and/or major psychiatric disorder
  • Metal in the head (dental permitted)
  • Pacemaker or other indwelling devices
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primed PAS 1A
Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Experimental: Unprimed PAS 1B
A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Sham Comparator: Sham PAS
A single session of sham paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Experimental: Primed PAS 2A
Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Experimental: Unprimed PAS 2B
A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Experimental: Primed PAS 1C
Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
Experimental: Primed PAS 2C
Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).
Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline peak-to-peak amplitude of motor evoked potential
Time Frame: Immediately before and within 60 minutes following intervention
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
Time Frame: Immediately before and within 60 minutes following intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Kate Frost, MS, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1601M82561

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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