NCT02249819终止1 期
Evaluating Anodal tDCS Preceding Aphasia Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Change in Picture-naming Accuracy Score
研究概览
简要总结
The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.
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)
盲法说明
Sequence of stimulation conditions was randomized across subjects.
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
- •≥ 18 years of age
- •First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- •Pre-morbidly right handed
- •Pre-morbidly fluent English speaker
- •Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
- •A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).
排除标准
- •Ongoing use of CNS-active medications
- •Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
- •Presence of additional potential tDCS risk factors:
- •Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- •Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
- •Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
- •A history of medication-resistant epilepsy in the family
- •Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
- •Pregnancy in women, as determined by self-report
结局指标
主要结局
Mean Change in Picture-naming Accuracy Score
时间窗: baseline, discharge
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
次要结局
未报告次要终点
研究者
Bruce Volpe
Principal Investigator
Northwell Health
研究点 (2)
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