TMS + taVNS for Stroke Recovery

Overseen By Bashar W Badran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Seizure reducers, Psychotropics, Stimulants, others

Disqualifiers: Psychiatric disorders, Neurological disorders, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining two therapies can improve recovery after a stroke. It uses Transcranial Magnetic Stimulation (TMS), which stimulates the brain with magnetic fields, and transcutaneous auricular vagus nerve stimulation (taVNS), which applies mild electrical pulses to a nerve in the ear. The aim is to determine if these treatments together enhance the brain's recovery ability more than either treatment alone. Individuals who have had a stroke and are in good health, without other neurological conditions, may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, especially those for seizures, psychiatric conditions, and any that lower the seizure threshold. You should also avoid stimulants, thyroid medication, and steroids.

What prior data suggests that this combination of TMS and taVNS is safe for stroke recovery?

Research has shown that both Transcranial Magnetic Stimulation (TMS) and transcutaneous auricular vagus nerve stimulation (taVNS) have been studied for their safety in people. Studies have found that taVNS, when combined with regular rehabilitation, significantly improves movement and sensory functions without major safety concerns, indicating it is generally well-tolerated.

TMS, another non-invasive treatment, has been explored for aiding stroke recovery. It uses magnetic fields to stimulate brain cells, which can assist in movement recovery. Research has not identified any major safety issues with TMS for this purpose.

Although this trial phase doesn't provide detailed safety data, both TMS and taVNS are non-invasive and have been safely used in other studies. This generally suggests they are safe, but discussing any concerns with a healthcare professional is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) combined with transcutaneous auricular vagus nerve stimulation (taVNS) for stroke recovery because it offers a novel approach compared to standard rehabilitation therapies. Most current treatments focus on physical therapy and medications to manage symptoms, but TMS and taVNS directly stimulate the brain and nervous system to promote neuroplasticity. This combination aims to enhance the brain's ability to rewire and recover function after a stroke more effectively. By targeting both brain activity and nerve signaling, this treatment has the potential to speed up recovery and improve outcomes in ways traditional methods cannot.

What evidence suggests that TMS combined with taVNS is effective for stroke recovery?

Research has shown that Transcranial Magnetic Stimulation (TMS) can improve movement and recovery in stroke patients. Studies have found that TMS supports motor rehabilitation. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise in aiding sensory recovery, possibly by enhancing the brain's adaptability. In this trial, participants will receive a combination of TMS and taVNS, which might enhance recovery further by targeting different brain areas. Early evidence suggests that this combination could be more effective than using either treatment alone. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 in good health who have had a stroke and are looking to improve their motor skills. It's not suitable for those with seizure disorders, pregnant women, people with metal implants above the neck, or individuals taking certain medications like psychotropics or seizure reducers.

Inclusion Criteria

You are in good health.

Exclusion Criteria

I am currently on medication to control seizures.

You have a problem with using drugs or being addicted to them, except for nicotine and caffeine.

You have metal implants in your head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined taVNS and TMS interventions to enhance motor cortex excitability

4-6 weeks

Multiple sessions, each lasting 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation
• Transcutaneous auricular vagus nerve stimulation (taVNS)

Trial Overview The study tests if using Transcranial Magnetic Stimulation (TMS) together with transcutaneous auricular vagus nerve stimulation (taVNS) can better enhance motor cortex excitability in stroke recovery than using each method separately.

How Is the Trial Designed?

Group I: TMS combined with taVNS Experimental Treatment 2 Interventions

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/46/NCT04130646/Prot_001.pdf

Version 3 Findings from these studies suggest that rTMS may develop into a promising adjuvant to conventional motor rehabilitation, however a recent large-scale trial was ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38604630/

Effect of transcranial direct current stimulation combined ... This study protocol aims to investigate the effect and neural mechanism of the combination of tDCS and taVNS on cognitive function in patients who had a stroke.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1676727/full

Clinical advances in transcutaneous auricular vagus nerve ... These findings suggest that taVNS paired with motor rehabilitation may promote sensory recovery in chronic stroke patients, potentially through ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04130646

Noninvasive VNS to Facilitate Excitability in Motor Cortex Study Overview. Brief Summary. Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162630/

Effect of transcranial magnetic stimulation combined with ... We will combine rTMS and taVNS, anticipating synergistic regulation through dual pathways to achieve multi-level neural remodeling effects and improve MCI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8820701/

Efficacy and safety of transcutaneous auricular vagus ... ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724004191

Transcutaneous auricular vagus nerve stimulation for post- ... ta-VNS has been proven effective as adjunctive therapy in patient with post-stroke depression. •. The synergistic approach of combining ta-VNS ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043414

tVNS in Stroke: A Narrative Review on the Current State ... Transcutaneous vagus nerve stimulation (tVNS) has shown promising evidence as a tool to reduce infarct size in animal models of hyperacute stroke.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10957639/

Transcutaneous auricular vagus nerve stimulation with task ... The combination of taVNS with TOT effectively improves upper extremity function in patients with subacute stroke, potentially through modulating the bilateral ...