Overview

This trial is active, not recruiting.

Condition stroke
Treatment transcranial magnetic stimulation (magstim)
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date September 2014
End date May 2015
Trial size 3 participants
Trial identifier NCT02188420, DPT_PAS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Experimental)
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.
transcranial magnetic stimulation (magstim) TMS
(Experimental)
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.
transcranial magnetic stimulation (magstim) TMS
(Experimental)
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.
transcranial magnetic stimulation (magstim) TMS
(Active Comparator)
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.
transcranial magnetic stimulation (magstim) TMS

Primary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Different Interpulse Intervals of Paired Associative Stimulation on Cortical Excitability in People With Chronic Stroke
Principal investigator Kate Frost, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.