Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke (TRAINS): Neuromodulatory Intervention to Ameliorate Cognition After Stroke for Individuals At Risk for VCID.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
研究概览
简要总结
The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.
详细描述
This is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tDCS) paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. The investigators will examine changes in cognitive performance induced by tDCS + cognitive therapy compared to sham tDCS + cognitive therapy. This study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke that occurred within 4 weeks of the study
- •Presence of cognitive impairment attributable to stroke
- •Between the ages of 18 and 90
- •Able to understand the nature of the study and give informed consent
- •Able to follow simple commands as evidenced by NIHSS subtest 1C =0
排除标准
- •History of chronic, serious, or unstable neurologic illness other than stroke
- •Current unstable medical illness(es)
- •History of reoccurring seizures or epilepsy
- •Current abuse of alcohol or drugs (prescription or otherwise)
- •Active and severe psychiatric disorder
- •Metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
- •Pregnancy
研究组 & 干预措施
Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
Participants will undergo 5 daily sessions of tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.
干预措施: tDCS (Device)
Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
Participants will undergo 5 daily sessions of tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.
干预措施: Cognitive Therapy (Behavioral)
Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
Participants will undergo 5 daily sessions of sham tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.
干预措施: sham tDCS (Device)
Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
Participants will undergo 5 daily sessions of sham tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.
干预措施: Cognitive Therapy (Behavioral)
结局指标
主要结局
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: Baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention
This psychometric test covers multiple domains of cognition, comes in multiple versions to avoid practice effect, is validated in the brain injury population and can be administered in 20-30 minutes. Possible scores on the RBANS range from 40 to 160 where a higher score indicates a better outcome.
次要结局
未报告次要终点
研究者
Kelly Sloane, MD
Assistant Professor of Neurology
University of Pennsylvania