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Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02619643
Collaborator
(none)
32
Enrollment
7
Arms
24
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation (Magstim)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Device Feasibility
Official Title:
Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline peak-to-peak amplitude of motor evoked potential [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.

    2. Change from baseline resting motor threshold [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02619643
    Other Study ID Numbers:
    • 1601M82561
    First Posted:
    Dec 2, 2015
    Last Update Posted:
    Nov 1, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 1, 2019