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

NCT ID: NCT02188420

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

N20-3ms, N20-5ms, N20+100ms, N20-7ms

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. Wash out period of 1 week then next level will be applied

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms)

Intervention Type: DEVICE

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.

N20-5ms, N20-3ms, N20-7ms, N20+100ms

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. Wash out period of 1 week then next level will be applied

Latency minus 7ms Wash out period of 1 week Latency plus 100ms Active comparator

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms)

Intervention Type: DEVICE

Transcranial Magnetic Stimulation 5ms

N20-7ms, N20-5ms, N20-3ms,N20+100ms

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. Wash out period of 1 week then next level will be applied

Group Type: EXPERIMENTAL

ranscranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms)

Intervention Type: DEVICE

Transcranial Magnetic Stimulation 7ms

N20-3ms, N20+100ms, N20-5ms, N20-7ms

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 100ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Wash out period of 1 week

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation Time 100ms

Intervention Type: DEVICE

Active Compator

Interventions

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 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.

Intervention Type: DEVICE

Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms)

Transcranial Magnetic Stimulation 5ms

Intervention Type: DEVICE

ranscranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms)

Transcranial Magnetic Stimulation 7ms

Intervention Type: DEVICE

Transcranial Magnetic Stimulation Time 100ms

Active Compator

Intervention Type: DEVICE

Other Intervention Names

TMS; Magstim; TMS; TMS; TMS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kate Frost, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Clinical and Translational Science Institute

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1406M51743

Identifier Type: -

Identifier Source: org_study_id