Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-89
SponsorNeurogrin Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cerogrin
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Cerogrin GroupExperimental treatment 1 intervention
Group B: Sham GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)2
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.
Time frame
Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)3
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.
Time frame
Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)4
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.
Time frame
Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)Secondary outcomes
1
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.
Time frame
Baseline to Week 4 (End of Intervention Period)2
Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI)
This method measures brain activity by detecting changes in blood flow.
Time frame
Baseline to Week 4 (End of Intervention Period)3
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.
Time frame
Baseline to Week 4 (End of Intervention Period)Sponsors and contacts
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Source ClinicalTrials.gov