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Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation (TVNS MCI)

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ClinicalTrials.gov Identifier: NCT03359902
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : August 2, 2021
Sponsor:
Collaborators:
Department of Health and Human Services
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Study Description
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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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcutaneous vagal nerve stimulation Device: Sham stimulation Not Applicable

Detailed Description:

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). Transcutaneous vagal nerve stimulation (tVNS) may ameliorate symptoms of MCI. The investigators have demonstrated, in patients with epilepsy, that VNS improves memory; however, tVNS has not been used to treat patients with MCI. tVNS can now be performed without surgery by transcutaneous stimulation of the auricular branch with electrodes on the external ear. tVNS has the potential to improve cognition and may even alter the course of decline in patients with MCI. The investigators will employ a multimodal MRI-based neuroimaging approach combined with comprehensive and targeted cognitive testing to assess changes with tVNS in cognition in patients with MCI.

The investigators will evaluate the effects of tVNS on patients who have been diagnosed with MCI as well as healthy older controls. Very little in the way of mechanistic data or understanding of individual differences in response to tVNS in MCI/AD has been published. Thus, this is a necessary study to evaluate the potential utility of tVNS to enhance cognitive performance in patients with MCI. These data may serve as a platform for supporting the development of a clinical treatment trial with this technology.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Initial tVNS
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
Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width

Device: Sham stimulation
Sham stimulation will be performed using electrodes placed on earlobe
Experimental: Initial Sham
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
Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width

Device: Sham stimulation
Sham stimulation will be performed using electrodes placed on earlobe


Outcome Measures
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Primary Outcome Measures :
  1. Rey AVLT [ Time Frame: 5-10 minutes ]
    Assessment of delayed recall including ability to prevent intrusion


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359902


Contacts
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Contact: Brianna J Akers, B.S. 352-376-1611 ext 107675 briannamakers@ufl.edu
Contact: John B Williamson, Ph.D john.williamson@neurology.ufl.edu

Locations
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United States, Florida
HealthStreet Recruiting
Gainesville, Florida, United States, 32608
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Aidan J Murphy, B.A.    352-548-6000 ext 103329    aidanjmurphy@phhp.ufl.edu   
Principal Investigator: John B Williamson, Ph.D         
Sub-Investigator: Damon G Lamb, Ph.D         
Sub-Investigator: Ronald Cohen, Ph.D         
Sub-Investigator: Eric Porges, Ph.D         
Sub-Investigator: Faming Liang, Ph.D         
Sponsors and Collaborators
University of Florida
Department of Health and Human Services
National Institute on Aging (NIA)
Investigators
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Principal Investigator: John B Williamson, Ph.D University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03359902    
Other Study ID Numbers: IRB201600730 -N-A
R21AG054876 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Florida:
Mild Cognitive Impairment
Vagal Nerve Stimulation
tVNS
Alzheimer's disease
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders