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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)]
• Change from Baseline in Stroop Test Score [Срок оценки: 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 [Срок оценки: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)]

Вторичные конечные точки (3)

• Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI) [Срок оценки: Baseline to Week 4 (End of Intervention Period)]
• Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI) [Срок оценки: Baseline to Week 4 (End of Intervention Period)]
• Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis [Срок оценки: Baseline to Week 4 (End of Intervention Period)]

Критерии участия

Критерии включения

• 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.
• For both diagnoses:
• 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).
• For vascular dementia: independence in daily living impaired.
• For vascular mild cognitive impairment: independence in daily living preserved.
• K-MMSE-II score ≥ 18 and CDR score 0.5 to 1.0 at screening.
• Stable cognitive-enhancing medication (if applicable) for ≥4 weeks before baseline.
• Availability of a caregiver (at least 8 hours/week contact).
• Females of childbearing potential: agreement to use medically acceptable contraception during the study.
• Provided written informed consent.
• Willingness to comply with study protocol.

Критерии исключения

• 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.
• MRI contraindications (e.g., claustrophobia, metal implants, contrast agent allergy).
• Auricular skin disease or condition preventing device use.
• Inability to comply with study procedures.
• Pregnancy or breastfeeding.
• Participation in other clinical trials within 30 days before screening.
• Any other condition deemed inappropriate for participation by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Dongtan Hallym University Sacred Heart Hospital — Hwaseong-si

Идентификаторы

NCT: NCT07149038 · NG-VCI-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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