Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation

NCT ID: NCT02619643

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Primed PAS 1A

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Unprimed PAS 1B

A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Sham PAS

A single session of sham paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Primed PAS 2A

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Unprimed PAS 2B

A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Primed PAS 1C

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Primed PAS 2C

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Interventions

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Transcranial Magnetic Stimulation (Magstim)

Intervention Type DEVICE

Other Intervention Names

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TMS Magstim

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Frost, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

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1601M82561

Identifier Type: -

Identifier Source: org_study_id

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