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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerogrin Group | Experimental | Participants in this group will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. |
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| Sham Group | Sham Comparator | Participants in this group will use a sham device identical in appearance to the Cerogrin device but delivering no stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI) | This score evaluates the brain's perivascular space, which is related to cerebral small vessel disease. | Baseline to Week 4 (End of Intervention Period) |
| Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youngmin Park, Ph.D. | Contact | 82269536591 | youngminpk@neurogrin.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jaeho Kim, M.D., Ph.D. | Hallym University Dongtan Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongtan Hallym University Sacred Heart Hospital | Recruiting | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
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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) |
This method measures brain activity by detecting changes in blood flow. |
| Baseline to Week 4 (End of Intervention Period) |
| Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis | 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. | Baseline to Week 4 (End of Intervention Period) |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |