What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment being studied for its effects on motor cortex excitability in stroke patients. Common side effects of TMS include mild headaches, scalp discomfort at the stimulation site, tingling, and lightheadedness. Serious adverse events are rare but can include seizures, particularly in individuals with a history of epilepsy. Other treatments for stroke, such as medication and physical therapy, have their own side effects, but TMS is generally well-tolerated with a low risk of severe complications.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) is a noninvasive neuromodulation therapy that has shown promise in modulating neuronal activity in the motor cortex, particularly for stroke rehabilitation. While TMS itself is FDA-approved for conditions like major depressive disorder and migraine, its application in stroke treatment is still under investigation. There are no specific FDA-approved drugs directly related to TMS for stroke, but the therapy aims to enhance motor recovery by stimulating brain regions involved in motor control. Other FDA-approved treatments for stroke typically include thrombolytics like alteplase (tPA) for acute ischemic stroke and various antiplatelet and anticoagulant medications for secondary prevention.

What other types of research exist?

Promising novel alternatives to Transcranial Magnetic Stimulation (TMS) for stroke patients include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in stroke rehabilitation. 2) Remote Electrical Neuromodulation, which uses nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute migraine pain, suggesting potential for broader neuromodulation applications. Both methods are non-invasive and have shown positive results in clinical trials.

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Procedure

TMS for Stroke

N/A

Recruiting

Led By Alexander Opitz, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Prior occurrence of unprovoked seizure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how using magnetic pulses can help improve movement in people who have had a stroke. The study aims to find the best way to use these pulses by looking at brain activity patterns during treatment. Magnetic pulses have been used in several medical and clinical research applications, including stroke treatment.

Who is the study for?

This trial is for individuals who have experienced a stroke over 6 months ago and are facing motor difficulties. Participants must be able to communicate in English. Those with metal or electric implants, recent botulinum toxin treatments in the upper extremities, current pregnancy or breastfeeding, or a history of seizures cannot join.

What is being tested?

The study is examining how transcranial magnetic stimulation (TMS) affects the excitability of the motor cortex in stroke survivors. It specifically looks at how different phases of brain wave rhythms influence this excitability.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or twitching of facial muscles during application. Rarely it can induce seizures but is generally considered safe.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a seizure without a known cause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Motor evoked potentials (MEPs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants Without Unilateral StrokeExperimental Treatment1 Intervention

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.

Group II: Participants With Unilateral StrokeExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial magnetic stimulation (TMS)

2013

Completed Phase 4

~540

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stroke treatments generally aim to restore blood flow, protect brain tissue, and promote recovery of function. Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique that uses magnetic fields to stimulate nerve cells in the brain, particularly in the motor cortex. This stimulation can enhance neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. For stroke patients, this is crucial as it can help in the recovery of motor functions that were impaired due to the stroke. By modulating neuronal activity, TMS can potentially improve motor control and reduce disability, making it a promising adjunctive therapy in stroke rehabilitation.