Stroke, Stroke Sequelae, Motor Activity
Conditions
Keywords
stroke, recovery, TMS, VNS, motor, motor cortex
Brief summary
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).
Interventions
DEVICETranscranial Magnetic Stimulation
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
non-invasive vagus nerve stimulation delivers electricity to the ear
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-80 * endorsing good health
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Combined taVNS and TMS | every 10 minutes following for 30 minutes | We will monitor and record adverse events of combined taVNS TMS intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | 4 Separate Visits of TMS/taVNS |
|---|---|
| Age, Customized Age 18-65 | 12 Participants |
| Race/Ethnicity, Customized White, non-hispanic | 12 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Safety of Combined taVNS and TMS
We will monitor and record adverse events of combined taVNS TMS intervention.
Time frame: every 10 minutes following for 30 minutes
Population: The population was analyzed for safety. The number of participants with an adverse event was recorded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TMS and taVNS | Safety of Combined taVNS and TMS | 0 Participants |