StrokeNCT04968743

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

A study testing Transcranial magnetic stimulation (TMS) in people with Stroke, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Stroke
What is being tested?: Transcranial magnetic stimulation (TMS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2021to 1 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Read the 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.

Conditions: Stroke
Being tested: Transcranial magnetic stimulation (TMS)
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial magnetic stimulation (TMS)Device
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.

Study groups in NCT04968743
Study group	Role	What they receive
Participants With Unilateral Stroke	Experimental	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. Receives: Device: Transcranial magnetic stimulation (TMS)
Participants Without Unilateral Stroke	Experimental	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. Receives: Device: Transcranial magnetic stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Normalized Motor Evoked Potential Amplitude by Mu-Rhythm Phase(MEPs)
Motor 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.
Measured: During the second experimental TMS-EEG session, up to 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20211 Oct 2025

First posted20 Jul 2021
Study start1 Oct 2021
Primary completion1 Oct 2025
Study completion1 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04968743
Sponsor's protocol ID: STUDY00012900
Status last verified: Sep 2026
First submitted: 16 Jul 2021
Last updated: 14 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
ClinicalTrials.gov ID: NCT04968743
Acronym / sponsor ID: STUDY00012900
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 1 Oct 2025 (actual)
Study completion: 1 Oct 2025 (actual)
First posted: 20 Jul 2021 (actual)
Results: Posted 14 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Participants With Unilateral Stroke	Experimental	Device: Transcranial magnetic stimulation (TMS)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 Unilateral Stroke	Experimental	Device: Transcranial magnetic stimulation (TMS)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Participants With Unilateral Stroke, Participants Without Unilateral Stroke

Primary outcome

Normalized Motor Evoked Potential Amplitude by Mu-Rhythm Phase(MEPs)
Time frame: During the second experimental TMS-EEG session, up to 3 hours
Motor 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.

Results and safety

Results posted to the registry on 14 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Unilateral Stroke	12	11
Participants Without Unilateral Stroke	12	12

Primary outcome: Normalized Motor Evoked Potential Amplitude by Mu-Rhythm Phase(MEPs)

Time frame: During the second experimental TMS-EEG session, up to 3 hours. Mean (Standard Error). Unit: Millivolts normalized

Measure	Participants With Unilateral Stroke - Affected Hemisphere n = 11	Participants With Unilateral Stroke - Unaffected Hemisphere n = 11	Participants Without Unilateral Stroke - Left Hemisphere n = 12	Participants Without Unilateral Stroke - Right Hemisphere n = 12
Peak	0.9528 (0.0166)	0.9659 (0.0147)	0.9674 (0.0213)	0.9648 (0.0090)
Falling Phase	0.9790 (0.0103)	0.9942 (0.0189)	0.9532 (0.0242)	0.9880 (0.0122)
Trough	1.0439 (0.0200)	1.0291 (0.0109)	1.0638 (0.0228)	1.0428 (0.0169)
Rising Phase	1.0304 (0.0150)	1.0063 (0.0153)	1.0136 (0.0197)	1.0076 (0.0113)

Population analysed: Participants who completed the second experimental TMS-EEG session and had analyzable motor evoked potential data. One stroke participant withdrew before completion; therefore, the analysis population included 11 stroke survivors and 12 healthy volunteers. Values are reported by hemisphere/side.

Adverse events

Time frame: From the start of the first experimental session through completion of the second TMS-EEG session, up to 3 weeks per participant.Adverse events were monitored throughout the experimental MRI (session 1) and TMS-EEG session (session 2). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Unilateral Stroke	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Participants Without Unilateral Stroke	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Recruitment was more difficult than anticipated, resulting in 23 analyzed participants and lower statistical power than planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Stroke

RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Opitz, PhD principal investigator

University of Minnesota Department of Biomedical Engineering

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation (TMS) in people with Stroke, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Normalized Motor Evoked Potential Amplitude by Mu-Rhythm Phase(MEPs) (time frame: During the second experimental TMS-EEG session, up to 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.