Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment)
研究概览
简要总结
In a randomized controlled trial, efficacy of low-frequency, inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. An eyetracking-while-listening experiment will also be conducted before and after the intervention to investigate morphosyntactic processing.
详细描述
Efficacy of low-frequency (1hz), inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas. In other words, right frontal and right temporal sites will be targeted.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. The language assessment will be conducted using the Turkish Aphasia Language Assessment Test (ADD) and sets of pictures used to assess naming performance. ADD will be carried out before and after the intervention. Six picture sets will be used, one at baseline, four on different days during the intervention, and the last one immediately after the last day of the intervention. Cognitive screening will be conducted at baseline using the digit span test and Raven's colored progressive matrices. In addition, a pre- and post-treatment eyetracking-while-listening experiment will be conducted to investigate morphosyntactic processing in Turkish and to examine whether the two brain stimulation interventions differentially affect online (dynamic, time-dependent) measures of morphosyntactic processing. The eyetracking paradigm will request the participants to listen to Turkish sentences varying in morphosyntactic complexity (canonical versus noncanonical sentences) and to look at the picture (out of two pictures presented on the screen) corresponding to the sentence they are listening to.
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
The participant and the outcomes assessor (speech and language therapist conducting the assessment tests and the eyetracking experiment) will be blind as to which experiment group the participant belongs to. The investigator / clinician providing rTMS will not be blind to the experimental condition.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handedness,
- •Normal or corrected-to-normal vision and hearing,
- •Aphasia following cerebrovascular accident,
- •Cerebrovascular accident at least 6 months prior to enrolment in the study,
- •Satisfying current TMS safety guidelines (Rossi et al. 2009, 2021), which are:
- •No previous history of epilepsy,
- •No implant (e.g., cochlear implant) or stimulator (e.g., deep brain stimulation) in the head which may interact with the magnetic field,
- •No use of central nervous system active drugs that lower seizure threshold (as listed in the aforementioned guidelines)
排除标准
- •Left-handedness, ambidexterity,
- •Impaired and uncorrected vision or hearing,
- •No aphasia symptoms following cerebrovascular accident,
- •Time since cerebrovascular accident less than 6 months,
- •Violating current TMS safety guidelines (Rossi et al. 2009, 2021). In other words:
- •Having a previous history of epilepsy,
- •Having an implant (e.g., cochlear implant) or stimulator (e.g., deep brain stimulation) in the head which may interact with the magnetic field,
- •Taking central nervous system active drugs that lower seizure threshold (as listed in the aforementioned guidelines)
结局指标
主要结局
Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment)
时间窗: Immediately before the intervention (Day 0)
Baseline scores obtained from the Turkish Aphasia Language Assessment Test (ADD) Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 2 (during treatment)
时间窗: At the end of the first week of intervention (Day 5)
Scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the first week of treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 3 (post-treatment short-term)
时间窗: Immediately after the intervention (Day 10)
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 5 (post-treatment long-term)
时间窗: 6 months after the intervention
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) six months after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Picture Naming Scores Time 1 (pre-treatment)
时间窗: Immediately before the intervention (Day 0)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 2 (during treatment)
时间窗: At the end of the first week of intervention (Day 5)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 4 (post-treatment medium-term)
时间窗: 1 month after the intervention
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) one month after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Picture Naming Scores Time 3 (post-treatment short-term)
时间窗: Immediately after the intervention (Day 10)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 4 (post-treatment medium-term)
时间窗: 1 month after the intervention
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 5 (post-treatment long-term)
时间窗: 6 months after the intervention
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Eye movements Time 1 (pre-treatment)
时间窗: Immediately before the intervention (Day 0)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
Eye movements Time 2 (post-treatment)
时间窗: Immediately after the intervention (Day 10)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
次要结局
未报告次要终点
研究者
Talat Bulut
Assist. Prof. Dr.
Medipol University