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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS combined with taVNS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Combined taVNS and TMS | We will monitor and record adverse events of combined taVNS TMS intervention. | every 10 minutes following for 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
No plan to share data except through peer-review.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS and taVNS | Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 Separate Visits of TMS/taVNS | Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Combined taVNS and TMS | We will monitor and record adverse events of combined taVNS TMS intervention. | The population was analyzed for safety. The number of participants with an adverse event was recorded. | Posted | Count of Participants | Participants | every 10 minutes following for 30 minutes |
|
|
Up to 8 months
There are no adverse events reported in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMS Combined With taVNS | Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor-Faculty | Medical University of South Carolina | (843) 792-6076 | badran@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 | Apr 2, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2020 | Jun 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| transcutaneous auricular vagus nerve stimulation (taVNS) | Device | non-invasive vagus nerve stimulation delivers electricity to the ear |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |