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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04968743
Enrollment
24
Registered
2021-07-20
Start date
2021-10-01
Completion date
2025-10-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DEVICETranscranial 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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Normalized Motor Evoked Potential Amplitude by Mu-Rhythm Phase(MEPs)During the second experimental TMS-EEG session, up to 3 hoursMotor evoked potential amplitude was recorded from the first dorsal interosseous muscle by electromyography during EEG-guided phase-targeted single-pulse transcranial magnetic stimulation. Motor evoked potentials were measured at four phases of the ongoing mu rhythm: peak, falling phase, trough, and rising phase. Values are reported as normalized millivolts, with higher values indicating greater motor cortex excitability.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexander Opitz, PhD

University of Minnesota Department of Biomedical Engineering

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
Age, Continuous57.7 years
STANDARD_DEVIATION 11.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026