CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
Transcutaneous vagal nerve stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03359902
NCT03359902N/ACompleted

Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation

University of Florida·interventional·Posted Dec 2, 2017·Updated Oct 24, 2023

In Brief

A clinical study evaluating Transcutaneous vagal nerve stimulation and Sham stimulation for Mild Cognitive Impairment. Completed, enrolled 59 participants across 3 sites.

Detailed Summary

Patients with amnestic mild cognitive impairment (MCI) often have compromised quality of life (QOL). Cognitive impairment is a major contributor to decrements in QOL and progression of MCI often leads to loss of independence and withdrawal from social participation. MCI, in many patients, is an early expression of neurodegenerative disease. Patients with MCI frequently convert to Alzheimer's disease (AD) (12-16 percent by some estimates per year). Treatments for MCI are of limited scope and availability and of limited effectiveness. Thus, there is great need for treatments that can improve cognition and extend QOL in patients with MCI. The investigators propose to investigate the effect of a non-invasive and safe intervention that should have direct influence on brain systems underlying AD, transcutaneous vagal nerve stimulation (tVNS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 2, 2017
Enrollment StartJan 1, 2018
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.6 years ago

Interventions

Transcutaneous vagal nerve stimulationdevice

Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width

Sham stimulationdevice

Sham stimulation will be performed using electrodes placed on earlobe