Finding an Optimal Latency for Paired Associative Stimulation in People With Chronic Stroke

Sponsor
University of Minnesota (Other)
Overall Status
Unknown status
CT.gov ID
NCT02188420
Collaborator
(none)
3
1
4
27
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Study Details

Study Description

Brief Summary

After a stroke, there is an exaggerated inhibitory influence from the non-stroke hemisphere to the stroke hemisphere. Brain stimulation using repetitive transcranial magnetic stimulation (rTMS) to the non-stroke hemisphere can decrease this inhibition. Paired Associative Stimulation (PAS) may be a more effective way to produce this same inhibition, as shown in healthy subjects. However, it is not known whether this will translate to people with stroke. PAS consists of a peripheral nerve stimulus paired a short time later with a cortical stimulus to change the excitability within the brain. Thus the investigators will apply PAS to people with stroke, but the investigators need to first determine the most effective interpulse interval (IPI) between the peripheral and cortical stimuli. Our research question is which of three different IPIs is most effective in changing the excitability of the brain.

The purpose of this study is to determine the optimal IPI between a peripheral nerve pulse and a cortical stimulus that will be most effective in changing excitability of the brain in people with chronic stroke. The investigators hypothesize that the cortical excitability of the nonstroke hemisphere will be most inhibited with the latency-5ms condition.

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

Detailed Description

Numerous PAS studies have been done in healthy subjects and all have been done safely. The proper interpulse interval in healthy individuals between the peripheral nerve stimulus and the cortical stimulus is known to be "latency-5ms." However, this may be different in individuals with stroke.

Specific Aim: what is the optimal interpulse interval to achieve the maximum inhibitory effect in the nonstroke hemisphere?

We will recruit three subjects with chronic stroke. Electroencephalography (EEG) will be used to determine the latency between the peripheral nerve stimulus and the sensory evoked potential in each subject. We will then assess the following IPIs on each subject in a random order: "latency" - 3ms, -5ms and -7ms. There will be a fourth condition of "latency" + 100ms (known to have no effect) to be used as a control. The washout period will be at least one week between each of these conditions.

The optimal IPI will be determined from these tests by comparing single pulse transcranial magnetic stimulation (TMS) measures for cortical excitability. Prior to each treatment, each subject will receive 20 single pulse cortical stimuli to serve as pretest data. The post tests for each condition will consist of 20 single pulse cortical stimuli at 0, 5, 10, 15, 30, 45 and 60 minutes after the PAS condition. Data analysis will consist of a single-subject analysis with the two standard deviation bandwidth method of each post-test compared to pre-test.

We hypothesize that there will be no adverse advents and that this optimal IPI will be "latency"-5ms.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effect of Different Interpulse Intervals of Paired Associative Stimulation on Cortical Excitability in People With Chronic Stroke
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
May 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Latency minus 3ms

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.

Device: Transcranial Magnetic Stimulation (Magstim)
Other Names:
  • TMS
  • Magstim
  • Experimental: Latency minus 5ms

    Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.

    Device: Transcranial Magnetic Stimulation (Magstim)
    Other Names:
  • TMS
  • Magstim
  • Experimental: Latency minus 7ms

    Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.

    Device: Transcranial Magnetic Stimulation (Magstim)
    Other Names:
  • TMS
  • Magstim
  • Active Comparator: Latency plus 100ms

    Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" + 100ms), known to have no effect, where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.

    Device: Transcranial Magnetic Stimulation (Magstim)
    Other Names:
  • TMS
  • Magstim
  • Outcome Measures

    Primary Outcome Measures

    1. Change in cortical excitability using single TMS pulses [Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.]

      Assess average size of 20 motor evoked potentials via electromyography (EMG) signal resulting from single TMS pulses to the motor cortex. Measurements taken before and after paired associative stimulation treatment at each session.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • stroke (ischemic or hemorrhagic) of greater than 6 months duration

    • impairment in the paretic hand

    • over 18 years old

    • male or female

    • on mini mental status exam must have score of 22 or higher

    • must have elicitable motor evoked potential (MEP)

    Exclusion Criteria:
    • seizure within the past two years

    • receptive aphasia

    • epileptogenic medication

    • major psychiatric disorder

    • other interfering comorbidities

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Clinical and Translational Science Institute Minneapolis Minnesota United States 55414

    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:
    NCT02188420
    Other Study ID Numbers:
    • DPT_PAS
    First Posted:
    Jul 11, 2014
    Last Update Posted:
    Feb 24, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by University of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2016