Paired Associative Stimulation in Stroke

April 20, 2022 updated by: Xingbao Li, Medical University of South Carolina

Paired Associative Stimulation Modulates Motor Excitability and Plasticity in Chronic Stroke Patients

Stroke is the third most common cause of death in the United States after heart disease and cancer, and the leading cause of long-term disability. This work will develop an innovative brain stimulation method (paired associative stimulation) which might set the stage for a new treatment for stroke rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is the third most common cause of death in the United States after heart disease and cancer. An innovative recovery treatment is in demand for stroke motor recovery. Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS motor-evoked potentials (MEP's). The investigators will also compare post-stroke patients to healthy controls on the modulation effect of PAS and motor behavior measures.

Aim1. To investigate whether PAS (PAS25 or PAS10) can modulate motor excitability and plasticity;

Aim2. To investigate whether PAS can modify motor behaviors measures in both post-stroke patients and healthy controls;

Aim3. To investigate whether post-stroke patients show different modulation of PAS on both cortical plasticity and motor behavior measure compared to healthy controls.

For this study the investigators will enroll a total of 10 chronic stroke patients and 10 neurologically healthy controls matched for age and gender. Participants will have 4 visits. The first visit is for screening. They will receive either sham PAS or real PAS25 or real PAS10 at each following treatment visit.

Experimental Methods: Clinical Behavioral Measures: Handgrip; Nine-hole Peg Test; Wolf Motor Function Test; Imaging protocol: T1 weighted anatomical image, fluid attenuation inversion recovery (FLAIR) and diffusion tensor imaging (DTI); Stimulation locations: Left primary motor (M1); right median nerve; PAS methods: TMS stimulation will be delivered at 25 ms or 10 ms or 100 ms after median nerve stimulation.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-80 years old;
  2. first-ever ischemic stroke involving only one hemisphere;
  3. Patient demonstrates at least 10 degrees of voluntary finger, thumb and wrist extension; ;
  4. 6 - 24 months after ischemic stroke

Exclusion Criteria:

  1. Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/epidural hematoma;
  2. Bihemispheric ischemic strokes;
  3. History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records or current on anticoagulant;
  4. Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord disease affecting upper extremity motor function;
  5. Documented history of dementia prior to index event;
  6. Presence of any MRI/TMS risk factors such as (a) an electrically, magnetically or mechanically activated implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; (b) non-fixed metal in any part of the body, including a previous metallic injury to eye [all jewelry will be removed during stimulation]; (c) pregnancy, since the effect of TMS on the fetus is unknown, females of child bearing age will have to undergo a pregnancy test to confirm eligibility; (d) history of seizure disorder or post-stroke seizures. This last exclusion criterion applies only to the modulation portion of the proposal; (e) median nerve is damaged

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAS 10: TMS and median nerve stimulation
Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation. The interval between median nerve stimulation and TMS was chosen to be 10 ms, which is called PAS10. PAS 10: TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.
Experimental: PAS 25:TMS and median nerve stimulation
PAS 25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. PAS 25:TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.
Sham Comparator: PAS100:TMS and median nerve stimulation
PAS Control Paradigm: The interval between median nerve stimulation and TMS was chosen to be 100 ms, which is called PAS100. PAS100:TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracortical facilitation
Time Frame: 10-day treatment
the peak magnitude of MEP
10-day treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical behavioral measures-Handgrip
Time Frame: 10-day treatment
hand grip strength
10-day treatment
Nine-hole peg test
Time Frame: 10-day treatment
screening tool to administer Portable assess finger dexterity and median nerve function
10-day treatment
wolf motor function test
Time Frame: 10-day treatment
To measure upper extremity motor ability through timed and functional tasks
10-day treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00040369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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