StrokeNCT04130646
Noninvasive VNS to Facilitate Excitability in Motor Cortex
A study testing Transcranial Magnetic Stimulation and transcutaneous auricular vagus nerve stimulation (taVNS) in people with Stroke and Stroke Sequelae, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke Sequelae, Motor Activity
- What is being tested?
- Transcranial Magnetic Stimulation and transcutaneous auricular vagus nerve stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 6 Dec 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- endorsing good health
Who cannot join
- no TMS-induced motor cortex excitability changes in response to 20Hz motor cortex rTMS
- active psychiatric or neurological disorders
- history of CNS disease, concussion, overnight hospitalization, or other neurologic sequelae, tumors, seizures, frequent or severe headaches
- metal implanted above the neck
- currently taking seizure reducing medications
- currently taking psychotropic medications
Show all 15Show fewer
- any psychotropic medication taken within 5 half-lives of procedure time
- abuse or dependence of drugs (excluding nicotine and caffeine)
- currently taking medications that lower the seizure threshold
- taking any of the stimulants, thyroid medication, or steroids
- implanted devices/ferrous metal of any kind
- history of seizure or seizure disorder
- inability to determine motor threshold.
- Pregnant females and children under the age of 18 will be excluded for safety reasons
- No vulnerable populations or special classes of subjects will be considered for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability
Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.
Read the detailed description
The investigators aim to determine the effects of taVNS on motor cortex excitability. The hypothesis is that taVNS alone (sham rTMS + active taVNS) will induce increases in motor cortex excitability (post-stimulation compared to baseline). The investigators expect these changes will be of a lesser magnitude than those of TMS alone (active rTMS + sham taVNS) due to the indirect mechanistic approach of taVNS. Another aim is to determine whether taVNS-paired TMS is more effective at inducing cortical excitability than TMS alone, as it is hypothesized that pairing two forms of neuromodulation (active rTMS + active taVNS) will increase TMS-induced cortical excitability in the motor cortex when compared to single modality approaches (active rTMS + sham taVNS; sham rTMS + active taVNS). Furthermore, it is expected that this increase is timing sensitive, and the paired approach will induce larger TMS-induced cortical excitability compared to unpaired neuromodulation (active taVNS + active taVNS).
- Conditions
- Stroke, Stroke Sequelae, Motor Activity
- Being tested
- Transcranial Magnetic Stimulation, transcutaneous auricular vagus nerve stimulation (taVNS)
- Keywords
- stroke, recovery, TMS, VNS, motor, motor cortex
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
transcutaneous auricular vagus nerve stimulation (taVNS)Device
non-invasive vagus nerve stimulation delivers electricity to the ear
| Study group | Role | What they receive |
|---|---|---|
| TMS combined with taVNS | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation; Device: transcutaneous auricular vagus nerve stimulation (taVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Combined taVNS and TMS
We will monitor and record adverse events of combined taVNS TMS intervention.
Measured: every 10 minutes following for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Mar 2020
- Primary completion12 Jun 2023
- Study completion6 Dec 2024
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.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130646
- Sponsor's protocol ID
- 00089851
- Status last verified
- Apr 2025
- First submitted
- 30 Sep 2019
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data except through peer-review.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability
- ClinicalTrials.gov ID
- NCT04130646
- Acronym / sponsor ID
- 00089851
- Conditions
- Stroke, Stroke Sequelae, Motor Activity
- Keywords
- stroke, recovery, TMS, VNS, motor, motor cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.
Detailed description
The investigators aim to determine the effects of taVNS on motor cortex excitability. The hypothesis is that taVNS alone (sham rTMS + active taVNS) will induce increases in motor cortex excitability (post-stimulation compared to baseline). The investigators expect these changes will be of a lesser magnitude than those of TMS alone (active rTMS + sham taVNS) due to the indirect mechanistic approach of taVNS. Another aim is to determine whether taVNS-paired TMS is more effective at inducing cortical excitability than TMS alone, as it is hypothesized that pairing two forms of neuromodulation (active rTMS + active taVNS) will increase TMS-induced cortical excitability in the motor cortex when compared to single modality approaches (active rTMS + sham taVNS; sham rTMS + active taVNS). Furthermore, it is expected that this increase is timing sensitive, and the paired approach will induce larger TMS-induced cortical excitability compared to unpaired neuromodulation (active taVNS + active taVNS).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS combined with taVNS | Experimental | Device: Transcranial Magnetic Stimulation, Device: transcutaneous auricular vagus nerve stimulation (taVNS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- endorsing good health
Key exclusion criteria (15 listed)
- no TMS-induced motor cortex excitability changes in response to 20Hz motor cortex rTMS
- active psychiatric or neurological disorders
- history of CNS disease, concussion, overnight hospitalization, or other neurologic sequelae, tumors, seizures, frequent or severe headaches
- metal implanted above the neck
- currently taking seizure reducing medications
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 Stimulationtranscranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull | Device | TMS combined with taVNS |
| transcutaneous auricular vagus nerve stimulation (taVNS)non-invasive vagus nerve stimulation delivers electricity to the ear | Device | TMS combined with taVNS |
Primary outcome
Safety of Combined taVNS and TMS
Time frame: every 10 minutes following for 30 minutes
We will monitor and record adverse events of combined taVNS TMS intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data except through peer-review.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and transcutaneous auricular vagus nerve stimulation (taVNS) in people with Stroke and Stroke Sequelae, run by Medical University of South Carolina 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 15 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 20 Apr 2025. 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 20 Apr 2025). 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?
Safety of Combined taVNS and TMS (time frame: every 10 minutes following for 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2025.