Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
- Conditions
- Vascular DementiaMild Cognitive Impairment
- Registration Number
- NCT07149038
- Lead Sponsor
- Neurogrin Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI) Baseline to Week 4 (End of Intervention Period) This score evaluates the brain's perivascular space, which is related to cerebral small vessel disease.
Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI) Baseline to Week 4 (End of Intervention Period) This method measures brain activity by detecting changes in blood flow.
Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis Baseline to Week 4 (End of Intervention Period) Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) for changes in EEG power and relative EEG power by brainwave frequency band will be presented for each group. Statistical significance of the differences between groups will be tested using ANCOVA, with the indication (vascular dementia/vascular mild cognitive impairment) and baseline relative EEG power as covariates.