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Noninvasive VNS to Facilitate Excitability in Motor Cortex

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ClinicalTrials.gov Identifier: NCT04130646
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : November 28, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bashar Badran, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 30, 2019
First Posted Date  ICMJE October 17, 2019
Last Update Posted Date November 28, 2019
Estimated Study Start Date  ICMJE December 15, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
Mean change of EMG-recorded Motor-evoked potential from baseline to immediately after intervention [ Time Frame: Every 5 minutes up to 20 minutes following intervention end ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04130646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Noninvasive VNS to Facilitate Excitability in Motor Cortex
Official Title  ICMJE Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Stroke
  • Stroke Sequelae
  • Motor Activity
Intervention  ICMJE
  • Device: Transcranial Magnetic Stimulation
    transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
  • Device: transcutaneous auricular vagus nerve stimulation (taVNS)
    non-invasive vagus nerve stimulation delivers electricity to the ear
Study Arms  ICMJE
  • Active Comparator: Active taVNS, Active TMS
    Interventions:
    • Device: Transcranial Magnetic Stimulation
    • Device: transcutaneous auricular vagus nerve stimulation (taVNS)
  • Sham Comparator: Sham taVNS, Active TMS
    Interventions:
    • Device: Transcranial Magnetic Stimulation
    • Device: transcutaneous auricular vagus nerve stimulation (taVNS)
  • Sham Comparator: Active taVNS, Sham TMS
    Interventions:
    • Device: Transcranial Magnetic Stimulation
    • Device: transcutaneous auricular vagus nerve stimulation (taVNS)
  • Sham Comparator: Sham taVNS, Sham TMS
    Interventions:
    • Device: Transcranial Magnetic Stimulation
    • Device: transcutaneous auricular vagus nerve stimulation (taVNS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04130646
Other Study ID Numbers  ICMJE 00089851
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share data except through peer-review.
Responsible Party Bashar Badran, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP