Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Discourse: Picture Description
研究概览
简要总结
The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial.
This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.
详细描述
This is a prospective sham-controlled, cross-over design. Eligible participants must be over the age of 18 years, be > least 6 months post unilateral cortical stroke and diagnosed with mild to moderate non-fluent aphasia. Additional inclusion/exclusionary criteria have been specified in and approved by the IRB. Six to seven participants are expected to be recruited and screened, with the goal to enroll and complete the study with four individuals who will be randomly assigned to receive either sham or real condition first. The two intervention conditions include: 1) andodal tDCS (2mA) to the right posterior-lateral cerebellum and 2) sham tDCS to the right posterior-lateral cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during CILT followed by an additional 25 minutes of CILT alone. Each condition will be administered 3 days per week for two weeks for a total of 6 intervention sessions with a 4-week washout period between.
For tDCS (TCT-Research Version tDCS Stimulator, Hong Kong), two 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting the posterior lateral cerebellum and the cathode will be placed on the right shoulder. The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student researcher and will follow the guidelines of CILT.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over the age of 18 years
- •history of stroke
- •diagnosed with non-fluent aphasia.
- •be able to independently understand simple directions,
- •use some speech to communicate,
- •have access to reliable transportation (including taxi and/or other transportation services),
- •fluent in English.
排除标准
- •Pregnancy,
- •history of seizures,
- •any metal implants in the body (excluding dental fillings),
- •history of migraines,
- •psoriasis or eczema affecting the scalp,
- •history of a head injury such as a concussion
- •diagnosis of a mental health or neurological condition/disease.
结局指标
主要结局
Discourse: Picture Description
时间窗: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Procedural
时间窗: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Semantic
时间窗: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Picture Description
时间窗: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Story Retell
时间窗: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Phonemic
时间窗: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
次要结局
- Working Memory(Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2)
- Stroke Aphasia Quality of Life (SA-QOL)(Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2)