Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation

NCT03359902 | Completed Results FDA Device

• 3 other identifiers: IRB201600730 -N-AR21AG054876PRO00011145
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Vagal Nerve Stimulation; tVNS; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Rey Auditory Verbal Learning Test (Total Delayed Recall)

  The Rey Auditory Verbal Learning Test (RAVLT) is a verbal learning and memory task with a 15-item word list learned over 5 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 15) after a 30 minute delay.

  30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list

Study Arms (2)

Initial tVNS

EXPERIMENTAL

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).

Device: Transcutaneous vagal nerve stimulation; Device: Sham stimulation

Initial Sham

EXPERIMENTAL

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).

Device: Transcutaneous vagal nerve stimulation; Device: Sham stimulation

Interventions

Transcutaneous vagal nerve stimulation DEVICE

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

Initial Sham; Initial tVNS

Sham stimulation DEVICE

Sham stimulation will be performed using electrodes placed on earlobe

Initial Sham; Initial tVNS

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with amnestic mild cognitive impairment/mild Alzheimer's disease
• Preservation of independence in functional abilities
• Healthy aged adults without MCI to serve as control group

You may not qualify if:

• Other medical or neurological conditions that may be associated with significant impaired cognition (e..g, moderate to severe traumatic brain injury, epilepsy, etc...)
• Vascular dementia or other non-AD spectrum diagnosed neurodegenerative disorders
• Significant current depression
• Uncorrected vision/hearing loss
• Unable to undergo MRI exam

Sponsors & Collaborators

• University of Florida: lead
• Department of Health and Human Services: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

McKnight Brain Institute

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: John Williamson
• Organization: University of Florida

john.williamson@ufl.edu

352-548-6920

Study Officials

• John B Williamson, Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The sham stimulation experience is very similar to the tVNS stimulation experience. The electrodes are placed in a proximal location. Thus, without knowledge of the anatomy, the participants will be unable to determine which stimulation session is the tVNS one.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be assigned to either transcutaneous vagal nerve stimulation or sham for the first session, then switch to the other condition for their second session after a 1 week washout period.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 2, 2017
• Study Start: January 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 24, 2023
• Results First Posted: October 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)