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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968743
• Other study ID #: STUDY00012900
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: Alexander Opitz, PhD
• Phone: (612)-624-1094
• Email: aopitz[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 hours