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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI)(Baseline to Week 4 (End of Intervention Period))
- Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI)(Baseline to Week 4 (End of Intervention Period))
- Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis(Baseline to Week 4 (End of Intervention Period))