Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- The Western Aphasia Battery
研究概览
简要总结
With the present RCT, the investigators aimed at finding an optimal protocol for the neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ILAT (Intensive language action therapy) and 1-Hz rTMS to the right-hemispheric homologue of the anterior language area of Broca (pars triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.
详细描述
New neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are promising tools for neurorehabilitation, aphasia therapy included. Combined with behavioral techniques, Intensive Language-Action Therapy (ILAT), TMS could substantially amplify the beneficial effect of such behavioral therapy alone.
In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS (rTMS) to the right-hemispheric inferior frontal cortex (pars triangularis). Participant will be randomized to groups A and B. Participants in group A will receive a 2-week period of rTMS during naming training where they name pictures every ten second displayed on the screen, followed by 2-weeks of rTMS and naming combined with ILAT. Those in group B will receive the same behavioral therapy but TMS is replaced by sham stimulation.
Language performance will be measured before, during and after the interventions for 3 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years
- •presence of a single clinically documented stroke
- •chronic stage (at least 12 months post-stroke)
- •aphasia documented using the WAB test
- •no recurring utterances or severe global (total) aphasia
- •residual ability to understand simple task instructions
- •availability of information about medication
- •right-handedness
- •native speakers of Finnish.
排除标准
- •severe global (total) aphasia (Boston naming test less 3 points)
- •neglect, agnosia, severe vision impairment or hearing loss
- •severe attention or memory deficits
- •left-handedness
- •cardiac pacemaker or other stimulators
- •diagnosis of severe diabetes or severe depression
- •additional neurological diagnoses
- •other interventions, including speech therapy, in the same time period
结局指标
主要结局
The Western Aphasia Battery
时间窗: Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
aphasia quotient (AQ) measurement
次要结局
- The Action naming test(Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion)
- The Boston naming test(Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion)
研究者
Paula Heikkinen
Doctoral student
University of Helsinki