Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment

NCT07149038 | Recruiting

• 1 other identifier: NG-VCI-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Vascular Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

  The CDR-SB is a scale that evaluates a patient's cognitive function and ability to live independently. The scores range from 0 to 18, with higher scores indicating more severe cognitive impairment.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Korean Montreal Cognitive Assessment (K-MoCA) Score

  he K-MoCA is a cognitive screening tool used to detect mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Korean Mini-Mental State Examination-2 (K-MMSE-II) Score

  The K-MMSE-II is a cognitive screening test used to assess a person's cognitive function, with scores ranging from 0 to 30.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) Score

  The ADAS-cog 13 is a scale used to assess the severity of cognitive symptoms in Alzheimer's disease. Higher scores indicate greater cognitive impairment.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Controlled Oral Word Association Test (COWAT) Score

  This test measures a person's verbal fluency and executive function.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Stroop Test Score

  The Stroop test measures a person's cognitive flexibility and executive function.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

• Change from Baseline in Trail Making Test (TMT) Score

  The TMT is a neuro-psychological test of visual attention and task switching.

  Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)

Secondary Outcomes (3)

• Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI)

  Baseline to Week 4 (End of Intervention Period)

• Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI)

  Baseline to Week 4 (End of Intervention Period)

• Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis

  Baseline to Week 4 (End of Intervention Period)

Study Arms (2)

Cerogrin Group

EXPERIMENTAL

Participants in this group will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device.

Device: Cerogrin

Sham Group

SHAM COMPARATOR

Participants in this group will use a sham device identical in appearance to the Cerogrin device but delivering no stimulation.

Device: Sham Device

Interventions

Cerogrin DEVICE

Participants in this arm will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. This device non-invasively delivers electrical stimulation to the vagus nerve located on the outer ear, aiming to improve cognitive function.

Cerogrin Group

Sham Device DEVICE

Participants in this arm will use a sham device. This device is identical in appearance to the active Cerogrin device but delivers no electrical stimulation or therapeutic effect. The sham device serves as a control to compare outcomes with the active treatment group.

Sham Group

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurogrin Inc.: lead

Study Sites (1)

Dongtan Hallym University Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

RECRUITING

MeSH Terms

Conditions

Dementia, Vascular; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Jaeho Kim, M.D., Ph.D.

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngmin Park, Ph.D.

CONTACT

82269536591; youngminpk@neurogrin.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 29, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)