The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ege Aphasia Test
研究概览
简要总结
The aim of the study is to observe the effects of speech therapy and transcranial magnetic stimulation therapy in patients who develop anomic aphasia after stroke. Patients meeting the inclusion criteria will be randomly divided into groups. In the repetitive transcranial magnetic stimulation (rTMS) treatment group, a total of 10 sessions, 1 session per day, will be applied to the right inferior frontal gyrus area with a frequency of 1 Hz for 20 minutes. The control group patients will be given speech therapy in the same way, but no active magnetic stimulation will be given in rTMS sessions (sham application). Speech therapy will be given to each patient by the same physiotherapist, and the treatment will last a total of 10 days, 60 minutes a day. Minimental test (MMT), Ege aphasia test, aphasia quality of life scale (SAQOL-39) will be filled in to the patients before and after the treatment.
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)
盲法说明
Participants will not know their groups, and the transcranial magnetic stimulation applications will be done in similar conditions, except for no stimulation with the position of the coil. The masking will also be done for the care provider, investigator and the outcomes assessor, as the evaluator and the researcher who provides the randomization will be different, and the data recording will be kept without implying the groups.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke diagnosed with cranial MR examination causing unilateral hemiplegia
- •Post-stroke patients with anomic aphasia
- •40-70 years
- •Being able to read the basic instructions
- •Medically and neurologically stable patients
排除标准
- •Clinical condition that will constitute a contraindication to TMS (metallic implant, Cardiac pacemaker, pregnancy, breastfeeding, epilepsy, head trauma...)
- •Having previously had TMS treatment
- •Presence of Life-threatening disease and/or active systemic disease (chronic disease, malignancy ...)
- •Alcohol or drug addiction
- •Presence of neurodegenerative or psychiatric disorders
- •Pregnancy or breastfeeding status
- •Severe cognitive impairment
- •Having a history of previous epilepsy
- •Visual and auditory impairment
结局指标
主要结局
Ege Aphasia Test
时间窗: 2 weeks
Ege aphasia test (EAT): The test battery acquired in 2011 and used in the study consists of 8 subtests: speech style and characteristics, apraxia assessment, auditory / verbal comprehension, repetition, naming, visual understanding / reading, drawing figures / writing / sentences, mathematics. Although there is variability in the scoring of the EAT according to the subtests, generally 0 points are given to correct answers, and 1, 2 or more points are given to repeated and incorrect answers. The validity and reliability of the test was shown in 2013 by Atamaz et al.
次要结局
- Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )(2 weeks)
- Mini Mental Test(MMT)(2 weeks)
研究者
Kadir Kara M.D
Physician, Researcher
Ege University