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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  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.
• Change from Baseline in Korean Montreal Cognitive Assessment (K-MoCA) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  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.
• Change from Baseline in Korean Mini-Mental State Examination-2 (K-MMSE-II) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  The K-MMSE-II is a cognitive screening test used to assess a person's cognitive function, with scores ranging from 0 to 30.
• Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  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.
• Change from Baseline in Controlled Oral Word Association Test (COWAT) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  This test measures a person's verbal fluency and executive function.
• Change from Baseline in Stroop Test Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  The Stroop test measures a person's cognitive flexibility and executive function.
• Change from Baseline in Trail Making Test (TMT) Score — Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
  The TMT is a neuro-psychological test of visual attention and task switching.

Trial sites (1)

Other trials for the same condition