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临床试验/NCT04540783
NCT04540783Unknown不适用

The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training on Episodic Memory and Attention in Patients With Traumatic Brain Injury: a Double-blind, Randomized, Placebo-controlled Study

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)

研究概览

简要总结

Long-term sequelae in TBI is a well-recognized burn. We designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult TBI patients. To evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tDCS) in the dorsolateral prefrontal cortex (DLPFC), bilateral temporal cortex (CTB) and compare to sham stimulation, and online cognitive training. We expect that the active group will differ from the sham group, showing larger effect sizes in the cognitive assessment.

详细描述

Method: proof of concept study, randomized, double-blind, placebo-controlled. 36 adult patients will be recruited, with closed TBI for at least 6 months, of both sexes. The sequence of randomization will provide the allocation 1: 1: 1 in parallel groups: G1 n = 12 active (CTB), G2 n = 12 active (DLPFC), and G3 n = 12 (Sham). The tDCS will be held with the intensity of 2 mA for 20 minutes per session and online cognitive training (concurrent with the ETCC). All patients, after the screening and randomization, will make a baseline neuropsychological assessment (T0) and receive 10 sessions of stimulation concomitant to cognitive training. Patients will undergo neuropsychological reassessment one week (T1) and two months (T2) after the last tDCS session. We will evaluate performance on episodic memory tests, working memory and attention in the three periods (T0, T1, and T2). The significance adopted is the level of 5% (α = 0.05), analysis of 80% power and bicaudal curve. Analysis of the results will be done by intention to treat (ITT).

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)

盲法说明

sham device (by code)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis closed traumatic brain injury, cognitive complaints reported by the patient or caregiver.

排除标准

  • metal implants in the head, seizures, abnormal EEG, depressive symptoms

结局指标

主要结局

Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)

时间窗: up to 2 weeks

List of words

次要结局

  • Memory cognitive training(up to 2 weeks)
  • Attention cognitive training(up to 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

WELLINGSON SILVA PAIVA

Supervisor, Division of Neurosurgery

University of Sao Paulo General Hospital

研究点 (2)

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