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

NCT02188420 | Completed Results FDA Device

• 1 other identifier: 1406M51743
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

PAS; TMS; Stroke; Paired Associative Stimulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Cortical Excitability Using Single TMS Pulses

  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.

  Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.

Study Arms (4)

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

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

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

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

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. 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

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

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

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

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

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

ACTIVE COMPARATOR

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

Device: Transcranial Magnetic Stimulation Time 100ms

Interventions

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

Also known as: TMS, Magstim

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" - 5ms) DEVICE

Transcranial Magnetic Stimulation 5ms

Also known as: TMS

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

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

Transcranial Magnetic Stimulation 7ms

Also known as: TMS

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

Transcranial Magnetic Stimulation Time 100ms DEVICE

Active Compator

Also known as: TMS

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• seizure within the past two years
• receptive aphasia
• epileptogenic medication
• major psychiatric disorder
• other interfering comorbidities
• pregnancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Clinical and Translational Science Institute

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kate Frost
• Organization: University of Minnesota

612-626-0637

Study Officials

• Kate Frost, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 11, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Locations

US (1)