Actively Recruiting
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
Led by Neurogrin Inc. · Updated on 2025-11-18
24
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc. for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. Given the limited availability of effective pharmacological treatments for these conditions, the study aims to assess whether Cerogrin can enhance cognitive function through non-invasive neuromodulation. Twenty-four participants will be randomized to receive either the active Cerogrin device or a sham (non-stimulating) device. Daily use will occur at home for 30 minutes over a four-week intervention period. The full study duration, including baseline assessments and follow-up, will span up to three months. During this period, cognitive function, neural activity, and safety outcomes will be systematically evaluated. This feasibility trial represents a critical step toward expanding therapeutic options for vascular cognitive impairment.
CONDITIONS
Official 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 MRI showing subcortical lesions
- Severe white matter changes on MRI (Fazekas scale: deep white matter 6 2.5 cm or caps/bands 6 1.0 cm)
- Low cognitive performance with a Z-score less than -1.0 SD in at least one domain, adjusted for education, age, and sex
- Impaired daily living independence for vascular dementia or preserved independence for vascular mild cognitive impairment
- Korean Mini-Mental State Examination-2 score 18 or higher and Clinical Dementia Rating 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/week contact
- Females of childbearing potential agree to use medically acceptable contraception during the study
- Provided written informed consent
- Willing to follow the study protocol
You will not qualify if you...
- Dementia types other than vascular dementia, such as Alzheimer's disease, Lewy body dementia, or frontotemporal dementia
- Conditions causing cognitive decline like uncontrolled metabolic diseases, CNS infections, cerebrovascular disease, traumatic brain injury, or Parkinson's disease
- Severe psychiatric disorders including major depression, schizophrenia, or substance abuse
- Serious unstable physical health conditions
- Contraindications to MRI, such as claustrophobia, metal implants, or allergy to contrast agents
- Auricular skin diseases or conditions preventing device use
- Unable to comply with study procedures
- Pregnancy or breastfeeding
- Participation in other clinical trials within 30 days before screening
- Any other condition considered unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here