NCT07149038

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Neurogrin Inc. · Industry
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Cerogrin	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.
DEVICE	Sham 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.

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-08-29
• Last updated: 2025-11-18

Locations

1 site across 1 country: South Korea