MedPath

Noninvasive VNS to Facilitate Excitability in Motor Cortex

Not Applicable
Completed
Conditions
Stroke
Stroke Sequelae
Motor Activity
Interventions
Device: Transcranial Magnetic Stimulation
Device: transcutaneous auricular vagus nerve stimulation (taVNS)
Registration Number
NCT04130646
Lead Sponsor
Medical University of South Carolina
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Active taVNS, Active TMStranscutaneous auricular vagus nerve stimulation (taVNS)-
Sham taVNS, Active TMSTranscranial Magnetic Stimulation-
Active taVNS, Active TMSTranscranial Magnetic Stimulation-
Active taVNS, Sham TMStranscutaneous auricular vagus nerve stimulation (taVNS)-
Sham taVNS, Sham TMStranscutaneous auricular vagus nerve stimulation (taVNS)-
Sham taVNS, Active TMStranscutaneous auricular vagus nerve stimulation (taVNS)-
Active taVNS, Sham TMSTranscranial Magnetic Stimulation-
Sham taVNS, Sham TMSTranscranial Magnetic Stimulation-
Primary Outcome Measures
NameTimeMethod
Safety of Combined taVNS and TMSevery 10 minutes following for 30 minutes

We will monitor and record adverse events of combined taVNS TMS intervention.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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