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Noninvasive VNS to Facilitate Excitability in Motor Cortex

Primary Purpose

Stroke, Stroke Sequelae, Motor Activity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
transcutaneous auricular vagus nerve stimulation (taVNS)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring stroke, recovery, TMS, VNS, motor, motor cortex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Sham Comparator

Sham Comparator

Arm Label

Active taVNS, Active TMS

Sham taVNS, Active TMS

Active taVNS, Sham TMS

Sham taVNS, Sham TMS

Arm Description

Outcomes

Primary Outcome Measures

Mean change of EMG-recorded Motor-evoked potential from baseline to immediately after intervention
The study uses Motor Evoked Potentials (MEPs), which are EMG measurements of a targeted movement (in other words, electromyography on the thenar muscles will sense a "twitch" that may occur due to motor cortex stimulation by TMS). The sensitivity of the motor cortex to stimulation is correlated to the degree of thumb twitch. This MEP will be used as a functional measure of changes in motor cortex excitability, as the amount of muscle twitch (MEP) should change if the cortex is more sensitive to TMS stimulation. The baseline measurement will be taken in the 60 seconds preceding the intervention; the intervention will last 20 minutes; post-intervention MEPs will be measured at 1, 5, 10, 15, and 20 minutes following the end of the intervention.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2019
Last Updated
August 9, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04130646
Brief Title
Noninvasive VNS to Facilitate Excitability in Motor Cortex
Official Title
Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Sequelae, Motor Activity
Keywords
stroke, recovery, TMS, VNS, motor, motor cortex

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active taVNS, Active TMS
Arm Type
Active Comparator
Arm Title
Sham taVNS, Active TMS
Arm Type
Sham Comparator
Arm Title
Active taVNS, Sham TMS
Arm Type
Sham Comparator
Arm Title
Sham taVNS, Sham TMS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
Intervention Type
Device
Intervention Name(s)
transcutaneous auricular vagus nerve stimulation (taVNS)
Intervention Description
non-invasive vagus nerve stimulation delivers electricity to the ear
Primary Outcome Measure Information:
Title
Mean change of EMG-recorded Motor-evoked potential from baseline to immediately after intervention
Description
The study uses Motor Evoked Potentials (MEPs), which are EMG measurements of a targeted movement (in other words, electromyography on the thenar muscles will sense a "twitch" that may occur due to motor cortex stimulation by TMS). The sensitivity of the motor cortex to stimulation is correlated to the degree of thumb twitch. This MEP will be used as a functional measure of changes in motor cortex excitability, as the amount of muscle twitch (MEP) should change if the cortex is more sensitive to TMS stimulation. The baseline measurement will be taken in the 60 seconds preceding the intervention; the intervention will last 20 minutes; post-intervention MEPs will be measured at 1, 5, 10, 15, and 20 minutes following the end of the intervention.
Time Frame
Every 5 minutes up to 20 minutes following intervention end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data except through peer-review.

Learn more about this trial

Noninvasive VNS to Facilitate Excitability in Motor Cortex

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