Transcranial Direct Current Stimulation (tDCS) an Adjuvant to Intensive Speech Therapy in Chronic Post Stroke Aphasia
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Improvement in naming nouns as measured by Object Naming Test
研究概览
简要总结
The purpose of this study is to determine if transcranial direct current stimulation (tDCS) in conjunction with intensive speech therapy will improve sentence production and word retrieval in individuals with chronic post stroke aphasia.
详细描述
Participants from the study will be clients that are enrolled at Austin Speech Labs intensive speech therapy following the enrollment protocol. A total of six participants will be enrolled, they will be randomly assigned to sham and real groups. Three of the clients will receive real and other will receive sham tDCS.
Prior to receiving tDCS or speech therapy, the participants' comprehension will be assessed using the Western Aphasia Battery (WAB). If they have a score of lower than 50%, they will be excluded from the study. If they receive a score of greater than 50%, they will be asked to provide verbal and written consent by signing the consent form.
The Principal investigator will provide the consent form to both the caregiver and the participants.If necessary, the investigator will simplify the terminology to ensure comprehension. The investigator will explain that the purpose of this research intends to gather data in order to gain scientific knowledge and will not necessarily benefit the participant.
The participants in the experimental group and control group will receive a total of three hours of therapy. All participants will receive intensive- group, and two hours of individual therapy.
Experimental Group -- Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device. The anodal electrode will be placed over inferior frontal gyrus area or the perilesional area, if Broca's area is damaged and the cathodal electrode will be placed over the contralateral or orbital frontal on the right hemisphere. For both the Sham and the experimental group the stimulation will be ramped up for 45 seconds and ramped down for 15 seconds. For the experimental group the stimulation will be ramped up for 45 seconds and stay there for 20 min while for the sham group it will ramp down after the initial 45 seconds. The participants will receive three weeks of tDCS and continue receiving only intensive speech therapy for five weeks for three hours a day. Intensive speech therapy will continue in order to allow the neurons to be stimulated.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have suffered a left CVA
- •Demonstrate 50% or greater on the Auditory Verbal Comprehension section of the WAB
排除标准
- •Have any other type of neurological condition
- •Have any other medical conditions, such as seizures or implants
- •Have suffered a right CVA
- •Are receiving teletherapy
结局指标
主要结局
Improvement in naming nouns as measured by Object Naming Test
时间窗: After eight weeks of treatment
Nouns will be tested using An Object Naming Test by Dr.Judith Druks and Dr.Jackie Masterson
Improvement in naming Action verbs as measured by Northwestern Assessment Verbs Sentences
时间窗: After eight weeks of treatment
naming Action Verbs will be measured using Northwestern Assessment of Verbs(NAVS)
Improvement in sentence production as measured by NAVS
时间窗: After eight weeks of treatment
Sentence production will be measured using Northwestern Assessment of Verbs and Sentences(NAVS)
次要结局
- Improvement in picture description as measured by Western Aphasia Battery(After eight weeks of treatment)