NCT01277575终止3 期
Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy
University of Magdeburg6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- improvement of speaking
研究概览
简要总结
The investigators assess if repetitive, transcranial alternating current stimulation (rtACS) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. Further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lesion age at least 6 months
- •aphasia with at least moderate severity according to Aachener Aphasia Test (AAT)
- •age between 40 and 75
- •German-speaking (at a native speaking level)
排除标准
- •cognitive or speech-language therapy during the 2-weeks stimulation course
- •intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed)
- •additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy
- •(severe) dysarthria
- •untreated hypertension exceeding 160/100 mmHg (patients with treated hypertension and blood pressure below 160/100 mmHg can be included)
- •increased risk of vascular thrombosis
- •epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago)
- •dementias and neurodegenerative diseases
- •significant psychiatric disturbances, e.g. schizophrenia
- •major attention and/or memory deficits
- •major hearing loss
- •patients with uncorrected visual deficits
- •severe global aphasia
- •modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia)
- •electric or electronic implants (e.g. heart pacemakers)
- •metal artefacts located at the head
- •medication with impact on the central nervous system (e.g. antidepressant or sedative drugs)
- •participation in another trial
- •pregnant or breastfeeding women
结局指标
主要结局
improvement of speaking
时间窗: between baseline and 60 days after stimulation
assessed by the following tests: * Expressive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test * receptive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test
次要结局
- successful stabilization of language(60 days after stimulation)
- speaking functions 1 - communicative skills(baseline to 60 days after stimulation)
- speaking functions 2 - spontaneous speech faculty(baseline to 60 days after stimulation)
- speaking functions 3 - naming(baseline to 60 days after stimulation)
- speaking functions 4 - repeating(baseline to 60 days after stimulation)
- speaking functions 5 - understanding(baseline to 60 days after stimulation)
研究者
研究点 (6)
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