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Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Suffering from chronic stroke, resulting in self-reported motor deficits (stroke occurring more than 6 months before study enrollment)
  • Confident level of English language

Exclusion Criteria:

  • Metal or electric implant in the head, neck, or chest area
  • Upper extremity botulinum toxin treatment in the last 6 months
  • Pregnancy or breastfeeding
  • Prior occurrence of unprovoked seizure

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants With Unilateral Stroke

Participants Without Unilateral Stroke

Arm Description

Participants with self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics and MRI scan, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the unilateral stroke will be confirmed. In participants with stroke, TMS will be applied over the motor cortex on the affected and non-affected hemisphere at the intensity of up to 120% resting motor threshold.

Participants without self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the lack of unilateral stroke will be confirmed. In participants without stroke, TMS will be applied targeting at the intensity of up to 120% resting motor threshold both left and right hemisphere.

Outcomes

Primary Outcome Measures

Motor evoked potentials (MEPs)
Responses in the First Dorsi Interosseous muscle to transcranial magnetic stimulation (TMS) will be measured by electromyogram and reported in millivolts (mV). MEPs will be measured for participants with and without stroke at the second, experimental visit.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2021
Last Updated
March 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04968743
Brief Title
Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
Official Title
Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on motor cortex excitability in individuals who have suffered stroke and to study the influence of the phase of the oscillatory rhythm (mu frequency) on motor excitability in stroke individuals.
Detailed Description
Neurological disorders, including stroke, are associated with impaired movement leading to significant negative effects on quality of life. Transcranial magnetic stimulation (TMS) is increasingly being explored as a rehabilitation strategy to enhance plasticity in motor regions. However, it is not yet fully understood how TMS acts on motor circuits and what optimal stimulation parameters are. TMS is a noninvasive neuromodulation method which enables in vivo perturbation of neural activity in humans through the application of electromagnetic fields to the brain. TMS has an established safety profile and has been explored extensively in clinical trials for a range of neurological and psychiatric disorders. Particularly, in potential positive effects of TMS have been identified for stroke rehabilitation. However, significant variability in treatment outcomes across patients has been found, making it necessary to improve current stimulation protocols and to investigate basic mechanism of action . The investigators plan to study the effects of TMS to the motor cortex in individuals who suffered stroke for movement rehabilitation. The investigators plan to measure motor evoked potentials (MEPs) at different phases of the motor mu-rhythm measured with EEG. Mu rhythms are related to healthy movement execution. By this, the investigators characterize phase-dependent cortical excitability differences in stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants With Unilateral Stroke
Arm Type
Experimental
Arm Description
Participants with self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics and MRI scan, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the unilateral stroke will be confirmed. In participants with stroke, TMS will be applied over the motor cortex on the affected and non-affected hemisphere at the intensity of up to 120% resting motor threshold.
Arm Title
Participants Without Unilateral Stroke
Arm Type
Experimental
Arm Description
Participants without self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the lack of unilateral stroke will be confirmed. In participants without stroke, TMS will be applied targeting at the intensity of up to 120% resting motor threshold both left and right hemisphere.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
TMS will be administrated with a Magstim 70mm figure-8 coil allowing for focal stimulation. Single-pulse TMS will be applied at different phases, (0, 90, 180, 270 degrees - 4 stimulation conditions), of the ongoing mu-rhythm. Positioning of the TMS coil will be neuronavigated based on individual MRI scans. Stimulation will be applied in a closed-loop fashion while the participant is at rest and their EEG activity is recorded.
Primary Outcome Measure Information:
Title
Motor evoked potentials (MEPs)
Description
Responses in the First Dorsi Interosseous muscle to transcranial magnetic stimulation (TMS) will be measured by electromyogram and reported in millivolts (mV). MEPs will be measured for participants with and without stroke at the second, experimental visit.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Suffering from chronic stroke, resulting in self-reported motor deficits (stroke occurring more than 6 months before study enrollment) Confident level of English language Exclusion Criteria: Metal or electric implant in the head, neck, or chest area Upper extremity botulinum toxin treatment in the last 6 months Pregnancy or breastfeeding Prior occurrence of unprovoked seizure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Opitz, PhD
Phone
(612)-624-1094
Email
aopitz@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Miles Wischnewski, PhD
Email
mwischne@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Opitz, PhD
Organizational Affiliation
University of Minnesota Department of Biomedical Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Full or partial access to the raw data will be provided upon the request to the faculty / research staff of recognized research, medical, and educational institutions for educational and scientific purposes. The request should be sent via an institutional email and will be stored with the study materials. The request should include a short description of the scientific or educational aims.
IPD Sharing Time Frame
Data will be shared only upon request after the study has ended (within 6 months).
IPD Sharing Access Criteria
To receive access, Dr. Opitz needs to be contacted via an institutional e-mail including a short description of the scientific or educational aims.

Learn more about this trial

Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke

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