Neuromodulation of Executive Dysfunction in Patients With Acute Stroke Using Transcranial Direct Current Stimulation. A Randomized-triple Blinded Controlled Clinical Trial. MODUL-EXE Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Digit Span test
研究概览
简要总结
This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on executive functions in patients with an acute stroke affecting the frontal lobe or the basal ganglia. The study will include 40 acute stroke subjects. Participants will undergo a global cognitive assessment with the MoCA test and a specific assessment of executive functions with the abbreviated Wisconsin test, the five digit test and the digit span evaluation (a subtest from the Wechsler intelligence scale for adults-IV). Participants will then undergo real or sham stimulation with anodal tDCS combined with cognitive training of the main executive functions: working memory, inhibitory control and cognitive flexibility. After a 10-session intervention, a the baseline cognitive assessment will be repeated and subsequently, a follow-up of up to 12 months will be carried out.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis, by means of cranial MRI or CT scan, of ischemic/hemorrhagic stroke, involving the frontal cortex or its subcortical connections (basal ganglia), in one or both hemispheres.
- •The stroke occurred during the 3 months prior to inclusion in the study.
- •Cognitive impairment with a dis-executive profile demonstrated by a score > 26 in the Spanish version of the MoCA test, adjusted for the number of years of formal education.
- •Patients with functional independence prior to the stroke, defined as a modified rankin scale score < 3 points.
- •The patient gives informed consent.
排除标准
- •Presence of other pathologies that may be a potential cause of disability or cognitive impairment.
- •Moderate or severe aphasia that hinders communication.
- •Severe sensory and/or motor impairments that prevent the completion of the evaluation and/or intervention processes.
- •Presence of extensive vascular leukopathia (leukoaraiosis grade 3, 4).
- •History of epilepsy or seizures.
- •Presence of severe systemic pathology, including cardiac, hepatic or renal failure, active neoplasia.
- •Failure to meet any of the inclusion criteria recorded in the Screening for electrical stimulation of the University of Göttingen.
- •Presence of:
- •Electrical and/or metallic implants.
- •Anticonvulsant medication.
- •Tattoos in the area of electrode placement.
结局指标
主要结局
Digit Span test
时间窗: Post intervention: Six months after intervention
Evaluates working memory. Normal average reference: to have a digit span of 7 items (plus or minus 2), the greater the memory span, the better the result.
Montreal cognitive assessment
时间窗: Post intervention: Six months after intervention
Global cognitive assessment test that incorporates the evaluation of executive domains such as working memory, inhibition and others such as verbal fluency, delayed recall and visuospatial capacity
Five digit test
时间窗: Post intervention: Six months after intervention
Assessing inhibitory control. A numerical task divided into four components. The first component (reading) demands subjects to name numbers from 1 to 5 as fast as they can. On the second component (counting), they need to describe quantities from 1 to 5. The third component (choosing) involves a selective attention trial, where the subjects must not read the numbers, but rather tell how many numbers are present in each stimulus, in an incongruent condition. The last component (shifting) is similar to the choosing trial, but for each of the five stimuli, there is one previously where the subject must read the stimulus numbers. The test total scores will be used as the main measure in this study. Higher scores indicate worse performance.
Wisconsin Card Sorting Test, Brief version.
时间窗: Post intervention: Six months after intervention
Assess cognitive flexibility. Respondents are required to sort numbered response cards according to different principles and to alter their approach during test administration. The global number of categories achieved will be assesed, the greater, the better the result is.
次要结局
- modified rankin scale(Post intervention: 12 months after intervention)
- Return to work(Post intervention: 12 months after intervention)
- Beck's Depression Inventory(Post intervention: Six months after intervention)
- Apathy Evaluation Scale(Post intervention: Six months after intervention)
- WHOQOL-BREF scale(Post intervention: Six months after intervention)
研究者
Laura Amaya Pascasio
Medical Doctor, investigator
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental