Actively Recruiting
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment A Single-Center, Randomized, Double-Blind Feasibility Trial Comparing Cerogrin With Sham Control
Led by Neurogrin Inc. · Updated on 2025-11-18
24
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effectiveness and safety of Cerogrin, a medical device designed for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. This study addresses the limited availability of effective drug treatments for these conditions by assessing whether non-invasive stimulation can improve cognitive function. It is a randomized, double-blind feasibility trial conducted by Neurogrin Inc. to explore a potential new therapeutic option. Participants will be randomly assigned to two groups: one will use the active Cerogrin device that delivers electrical stimulation to the vagus nerve on the outer ear, while the other will use a sham device that looks identical but provides no stimulation. Each participant will use their assigned device daily at home for 30 minutes over a four-week intervention period. The study includes baseline assessments, the intervention period, and follow-up monitoring, lasting up to three months in total. During the study, participants will undergo evaluations of cognitive function using various tests such as the Clinical Dementia Rating, Korean Montreal Cognitive Assessment, and Alzheimer's Disease Assessment Scale. Brain imaging with MRI and functional assessments with EEG will also be performed to monitor neural activity. Safety and adherence will be closely observed throughout the study, with outcome measurements taken at baseline, after the four-week intervention, and at follow-up up to eight weeks post-intervention.
CONDITIONS
Brief Title
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 89 years
- Diagnosed with vascular dementia or vascular mild cognitive impairment within 1 year before screening, confirmed by subcortical lesions on MRI
- Severe white matter changes on MRI (Fazekas scale: deep white matter ≥ 2.5 cm or caps/bands ≥ 1.0 cm)
- Cognitive impairment with a Z-score below -1.0 SD in at least one domain adjusted for education, age, and sex
- For vascular dementia: impaired independence in daily living
- For vascular mild cognitive impairment: preserved independence in daily living
- K-MMSE-II score of 18 or higher and CDR score between 0.5 and 1.0 at screening
- Stable cognitive-enhancing medication for at least 4 weeks before baseline, if applicable
- Availability of a caregiver with at least 8 hours per week contact
- Females of childbearing potential agree to use acceptable contraception during the study
- Provided written informed consent
- Willing to comply with the study protocol
You will not qualify if you...
- Dementia other than vascular dementia (e.g., Alzheimer's disease, Lewy body dementia, frontotemporal dementia)
- Conditions causing cognitive decline such as uncontrolled metabolic diseases, CNS infections, cerebrovascular disease, traumatic brain injury, or Parkinson's disease
- Severe psychiatric disorders like major depression, schizophrenia, or substance abuse
- Serious unstable physical conditions
- Contraindications for MRI including claustrophobia, metal implants, or contrast allergies
- Auricular skin disease or conditions preventing use of the device
- Inability to comply with study procedures
- Pregnancy or breastfeeding
- Participation in other clinical trials within 30 days before screening
- Any condition deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive transcutaneous auricular vagus nerve stimulation using either the Cerogrin device or a sham device for comparison.
Weekly visits for up to 4 weeks
Duration - 4 weeks
Participants are monitored for outcomes and safety after the intervention ends.
1 visit at Week 8
Trial Site Locations
Total: 1 location
1
Dongtan Hallym University Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450
Actively Recruiting
Research Team
Y
Youngmin Park, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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