Cerogrin ear (auricular) vagus nerve stimulation for vascular dementia and vascular mild cognitive impairment

A Single-Center, Randomized, Double-Blind Feasibility Trial Assessing the Initial Efficacy and Safety of Cerogrin, a Medical Device for Auricular Vagus Nerve Stimulation, in Improving Cognition in Patients With Vascular Dementia or Vascular Mild Cognitive Impairment: A Comparison With Sham Control

This study tests whether daily at-home Cerogrin ear vagus nerve stimulation can help improve thinking and memory in people aged 55–89 with vascular dementia or vascular mild cognitive impairment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 55 Years to 89 Years
• Sex: All
• Sponsor: Neurogrin Inc. (Industry-sponsored)
• Locations: 1 site (Hwaseong-si, Gyeonggi-do)
• Trial ID: NCT07149038 on ClinicalTrials.gov

What this trial studies

This is a small, randomized, sham‑controlled feasibility trial of the Cerogrin auricular vagus nerve stimulation device in people with vascular dementia or vascular mild cognitive impairment. Twenty-four participants will be randomized to active stimulation or a non‑stimulating sham device and will use the device at home for 30 minutes daily during a four‑week intervention. Cognitive function, neural activity measures, and safety outcomes will be collected at baseline, during the intervention, and over follow‑up visits spanning up to three months. The goal is to generate preliminary data on whether non‑invasive neuromodulation can produce measurable cognitive or neural changes and is tolerated in this patient group.

Who should consider this trial

Good fit: Ideal candidates are adults 55–89 years old diagnosed within the past year with vascular dementia or vascular mild cognitive impairment with subcortical MRI lesions and marked white matter changes (Fazekas criteria), at least one cognitive domain z‑score < -1.0 adjusted for demographics, K‑MMSE‑II ≥ 18, CDR 0.5–1.0, stable cognitive medications for ≥4 weeks, and availability of a caregiver.

Not a fit: Patients without a vascular pattern of brain injury, with more advanced or non‑vascular dementias, those unable to tolerate or apply an ear stimulation device, lacking a caregiver or required visits, or with unstable medical/medication status are unlikely to benefit from this pilot intervention.

Why it matters

Potential benefit: If effective, this non‑invasive device could provide a new treatment option to help preserve or improve cognition in people with vascular cognitive impairment.

How similar studies have performed: Small pilot studies of auricular vagus nerve stimulation have shown mixed effects on cognition and mood, and the specific use for vascular cognitive impairment is largely novel and remains unproven.

Eligibility criteria

Inclusion Criteria

* Adults aged 55 to 89 years.
* Diagnosed with vascular dementia or vascular mild cognitive impairment within 1 year before screening, with subcortical lesions confirmed on MRI.
* For both diagnoses:
* Severe white matter hyperintensity on MRI (Fazekas scale: deep white matter ≥ 2.5 cm or caps/bands ≥ 1.0 cm).
* Z-score \< -1.0 SD in at least one cognitive domain (adjusted for education, age, and sex).
* For vascular dementia: independence in daily living impaired.
* For vascular mild cognitive impairment: independence in daily living preserved.
* K-MMSE-II score ≥ 18 and CDR score 0.5 to 1.0 at screening.
* Stable cognitive-enhancing medication (if applicable) for ≥4 weeks before baseline.
* Availability of a caregiver (at least 8 hours/week contact).
* Females of childbearing potential: agreement to use medically acceptable contraception during the study.
* Provided written informed consent.
* Willingness to comply with study protocol.

Exclusion Criteria

* Dementia other than vascular dementia (e.g., Alzheimer's disease, Lewy body dementia, frontotemporal dementia).
* Conditions causing cognitive decline (e.g., uncontrolled metabolic diseases, CNS infections, cerebrovascular disease, traumatic brain injury, Parkinson's disease).
* Severe psychiatric disorders (e.g., major depression, schizophrenia, substance abuse).
* Serious unstable physical conditions.
* MRI contraindications (e.g., claustrophobia, metal implants, contrast agent allergy).
* Auricular skin disease or condition preventing device use.
* Inability to comply with study procedures.
* Pregnancy or breastfeeding.
* Participation in other clinical trials within 30 days before screening.
* Any other condition deemed inappropriate for participation by the investigator.

Where this trial is running

Hwaseong-si, Gyeonggi-do

• Dongtan Hallym University Sacred Heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (Recruiting)

Study contacts

• Principal investigator: Jaeho Kim, M.D., Ph.D. — Hallym University Dongtan Sacred Heart Hospital
• Study coordinator: Youngmin Park, Ph.D.

Conditions Vascular Dementia; Mild Cognitive Impairment