Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04968743
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial magnetic stimulation (TMS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: Participants With Unilateral Stroke

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.

Device: Transcranial magnetic stimulation (TMS)
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.

Experimental: Participants Without Unilateral Stroke

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.

Device: Transcranial magnetic stimulation (TMS)
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 Measures :
  1. Motor evoked potentials (MEPs) [ Time Frame: 3 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968743


Contacts
Layout table for location contacts
Contact: Alexander Opitz, PhD (612)-624-1094 aopitz@umn.edu
Contact: Miles Wischnewski, PhD mwischne@umn.edu

Locations
Layout table for location information
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Alexander Opitz, PhD University of Minnesota Department of Biomedical Engineering
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04968743    
Other Study ID Numbers: STUDY00012900
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Data will be shared only upon request after the study has ended (within 6 months).
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases