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Behavioural Intervention

Transcutaneous vagal nerve stimulation for Mild Cognitive Impairment (TVNS MCI Trial)

N/A
Waitlist Available
Led By John B Williamson, Ph.D
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list
Awards & highlights

TVNS MCI Trial Summary

This trial will investigate whether a non-invasive and safe intervention, transcutaneous vagal nerve stimulation (tVNS), can improve cognition and extend quality of life in patients with amnestic mild cognitive impairment (MCI).

Eligible Conditions
  • Mild Cognitive Impairment

TVNS MCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rey Auditory Verbal Learning Test (Total Delayed Recall)

TVNS MCI Trial Design

2Treatment groups
Experimental Treatment
Group I: Initial tVNSExperimental Treatment2 Interventions
This group will receive transcutaneous vagal nerve stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (initial tVNS vs. initial Sham). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Group II: Initial ShamExperimental Treatment2 Interventions
This group will receive sham stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (initial tVNS vs. initial Sham). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous vagal nerve stimulation
2016
Completed Phase 2
~230
Sham stimulation
2006
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,005,005 Total Patients Enrolled
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,637 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,890 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
2018. "Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03359902.
~8 spots leftby Apr 2025
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