Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in Apathy Inventory Scale - Clinician
研究概览
简要总结
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.
详细描述
Post-stroke apathy is a condition where people show reduced emotions and reduced activity after their stroke, beyond that expected from their degree of weakness. It can occur with, or without, depression, and is associated with more disability and slower recovery. It is thought to be due to dysfunction of the front of the brain (prefrontal cortex). Importantly, there are no proven medical treatments for post-stroke apathy.
Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has the potential for alleviating post-stroke apathy. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. This offers potential advantages over medications as tDCS directly targets the brain, while medications need to travel through the bloodstream to reach the brain. TDCS is not an FDA-approved treatment for any condition, but previous trials have shown it may benefit movement and language recovery after stroke, as well as improve thinking ability. Studies have shown tDCS to be very safe with no serious adverse events in over 10,000 subjects studied.
This pilot study will involve three visits to Stony Brook University Hospital. The first is a baseline session where subjects perform all outcome measures but no tDCS is performed other than for familiarization. The second and third sessions are the stimulation sessions where subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome measures. The effects of tDCS for a single session are expected to only last for few hours. Subjects are to receive one type of stimulation in one session and another type in the other session. If this study finds a short term benefit of tDCS for post-stroke apathy it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke)
- •Stroke occurred at least one month prior to first stimulation session
- •Ability to provide informed consent
- •Availability of a family member / caregiver who knew the subject before the stroke and interacts with the subject on at least a weekly basis
- •Score of 6 or higher in initial apathy testing using Apathy Inventory - Clinician score
- •Speak English (required for quantifying apathy and performing the cognitive tests)
排除标准
- •Other potential cause of apathy including some neurodegenerative diseases, some psychiatric diseases, and anti-dopamine medication
- •Prior brain injury (e.g., Traumatic Brain Injury (TBI), stroke) without full motor and cognitive recovery based on patient, family or clinician report
- •Active medical illness (e.g., infection, delirium, etc.) that might affect arousal and cognitive function
- •Hypoarousal (inability to maintain eye opening without stimulation) from any cause (e.g., stroke, sleep deprivation)
- •Any history of epilepsy
- •Recent drug or alcohol abuse - within the past year
- •Pregnant or breastfeeding
- •Moderate to severe aphasia preventing subject from communicating fully
- •Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants
研究组 & 干预措施
tDCS stimulation A
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
干预措施: Transcranial Direct Current Stimulation (Device)
tDCS stimulation B
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Changes in Apathy Inventory Scale - Clinician
时间窗: at the beginning of each session and 1 day after each session.
次要结局
- Changes in EEG(before and after each stimulation within 2 hours.)
- Changes in Apathy Inventory Scale - Subject(before and after each stimulation within 2 hours.)
- Changes in Apathy Inventory Scale - Family/Caregiver(at the beginning of each session and 1 day after each session.)
- Actimeter(Actimeter is worn from the beginning of the study to end of study (20 to 30 days))
- Changes in Language Analysis tests(before and after each stimulation within 2 hours.)
- Changes in Cognitive Tasks(before and after each stimulation within 2 hours.)
研究者
Andrew Goldfine
MD
Stony Brook University