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Neurostimulation Device

TMS + taVNS for Stroke Recovery

N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Be older than 18 years old
Must not have
Currently taking seizure reducing medications
Pregnant females and children under the age of 18 will be excluded for safety reasons
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 5 minutes up to 20 minutes following intervention end

Summary

This trial investigates whether a combination of TMS and taVNS is more effective than either modality alone in motor cortex excitability.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include discomfort at the stimulation site, mild headaches, lightheadedness, or temporary hearing changes due to taVNS. TMS might cause scalp discomfort during application and has a rare risk of inducing seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication to control seizures.
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I am not pregnant and I am over 18 years old.
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I am taking medication that increases my risk of seizures.
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I have a history of seizures.
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I have not taken any psychiatric drugs recently.
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I am currently taking stimulants, thyroid medication, or steroids.
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My brain did not react to a specific brain stimulation test.
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I am currently on medication for my mental health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 5 minutes up to 20 minutes following intervention end
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 5 minutes up to 20 minutes following intervention end for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Interventional procedure

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Active taVNS, Active TMSActive Control2 Interventions
Group II: Sham taVNS, Sham TMSPlacebo Group2 Interventions
Group III: Active taVNS, Sham TMSPlacebo Group2 Interventions
Group IV: Sham taVNS, Active TMSPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,344 Total Patients Enrolled
73 Trials studying Stroke
62,256 Patients Enrolled for Stroke
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,719 Total Patients Enrolled
43 Trials studying Stroke
8,431 Patients Enrolled for Stroke

Media Library

Transcranial Magnetic Stimulation (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04130646 — N/A
Stroke Research Study Groups: Sham taVNS, Sham TMS, Active taVNS, Sham TMS, Sham taVNS, Active TMS, Active taVNS, Active TMS
Stroke Clinical Trial 2023: Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT04130646 — N/A
Transcranial Magnetic Stimulation (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130646 — N/A
~14 spots leftby May 2027
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