N/A N=59 Randomized Double-blind Basic Science

Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation

Mild Cognitive Impairment

Bottom Line

View on ClinicalTrials.gov: NCT03359902 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Rey Auditory Verbal Learning Test (Total Delayed Recall) — 6.43; 7.83 score on a scale — p=0.11

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous vagal nerve stimulation (Device); Sham stimulation (Device)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Rey Auditory Verbal Learning Test (Total Delayed Recall)	6.43; 7.83	0.11

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03359902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.