Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in cerebrospinal fluid flow
研究概览
简要总结
The purpose of this research is to demonstrate that mild stimulation of a nerve (trigeminal nerve) in the head can modulate blood flow in the brain. The modulated blood flow will restore the flow of cerebrospinal fluid (CSF) and this in turn can help improve waste clearance in the brain and prevent build up that may lead to disease.
详细描述
The goal of this clinical trial is to demonstrate that non-invasive stimulation of the trigeminal nerve can be used to restore blood flow and consequently modulate CSF flow into the brain parenchyma to facilitate brain waste clearance that is impaired in patients with AD. This study will collect brain MRI data on 20 healthy cognitively unimpaired adults receiving intermittent trigeminal nerve branch (V1) stimulation. Participants with recent mild traumatic brain injuries will also be enrolled to establish feasibility within a clinically relevant population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants :
- •Age 20-85 years
- •Willing and able to undergo all procedures
- •Free of any neurological (e.g., epilepsy, stroke, Parkinson's, brain tumors, moderate or severe traumatic brain injury), neuropsychiatric (e.g., schizophrenia, substance abuse, clinical depression), or developmental (e.g., autism, ADHD) or any other medical condition at the discretion of the PI and co-investigators
- •Inclusion Criteria - mTBI :
- •Age 20-65
- •Diagnosed with mild traumatic brain injury and be within 1-52 weeks post-injury
- •Willing and able to undergo all procedures
排除标准
- •Healthy Participants:
- •Contraindication to MRI
- •Known allergies to common electrode materials
- •Exclusion Criteria - mTBI:
- •Contraindications for MRI
- •Known allergies to common electrode materials
- •Candidates currently on cardiovascular medications which, in the opinion of the investigators, would introduce a confounding factor to glymphatic system function (i.e. ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers)
- •Candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB)
- •Candidates diagnosed with small vessel disease, vascular associated dementia (e.g. VCID), or renal disease
- •Candidates retinopathies or neuropathies that, in the opinion of the investigators, would prevent them from being able to complete the study or would introduce a confounding factor to glymphatic system function
- •Candidates with neurological disorders other than those attributed to their primary diagnosis (e.g. MS, PD, ALS, AD or other dementia, uncontrolled pain)
- •Candidates who have had a penetrating injury, craniotomy (with the exception of a burr hole (trephination) for resolution of acute subdural hematoma), or refractory subdural hematoma
- •Candidates with a history of seizures (except those in the acute or post-acute phases and are controlled)
- •Candidates who experienced a loss of consciousness greater than 24 hours as a result of their TBI
- •Candidates who, in the opinion of the investigators, are unable to feel a sensory referred sensation from the stimulation or successfully complete the electrode placement and testing fNIRs
研究组 & 干预措施
Healthy Controls
干预措施: V1 stimulation electrodes (Device)
Healthy Controls
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Mild traumatic brain injury (mTBI)
Participants with recent mTBI
干预措施: Functional near-infrared spectroscopy (fNIRS) (Device)
Mild traumatic brain injury (mTBI)
Participants with recent mTBI
干预措施: V1 stimulation electrodes (Device)
Mild traumatic brain injury (mTBI)
Participants with recent mTBI
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Healthy Controls
干预措施: Functional near-infrared spectroscopy (fNIRS) (Device)
Healthy Controls
干预措施: MAGNUS scanner (Device)
结局指标
主要结局
Change in cerebrospinal fluid flow
时间窗: Baseline to 90 minutes
MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.
Change in blood flow through the brain parenchyma - fNIRS
时间窗: Baseline to 4 hours
The fNIRS device will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.
Change in blood flow through the brain - MRI
时间窗: Baseline to 90 minutes
The MRI will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.
Change in cerebrospinal fluid flow
时间窗: Baseline to 90 minutes
MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.
次要结局
未报告次要终点