Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation

Mild Cognitive Impairment Clinical Trial

— TVNS MCI  

Official title:

Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359902
• Other study ID #: IRB201600730 -N-A
• Secondary ID: R21AG054876PRO00
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	McKnight Brain Institute	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Department of Health and Human Services, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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