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

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ClinicalTrials.gov Identifier: NCT02188420
Recruitment Status : Unknown
Verified February 2016 by University of Minnesota.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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
Stroke Device: Transcranial Magnetic Stimulation (Magstim) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : December 2016
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in cortical excitability using single TMS pulses [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188420


Locations
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United States, Minnesota
University of Minnesota Clinical and Translational Science Institute
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Kate Frost, MS University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02188420    
Other Study ID Numbers: DPT_PAS
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by University of Minnesota:
PAS
TMS
Stroke
Paired Associative Stimulation
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases