Cerebellar Transcranial Direct Current Stimulation to Augment Chronic Aphasia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to Post-treatment
研究概览
简要总结
People with post-stroke aphasia are left with some degree of chronic deficit for which current rehabilitative treatments are variably effective. This study investigates the behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with computerized naming therapy in stroke survivors with aphasia.
详细描述
The investigators will study the effect of right cerebellar transcranial direct current stimulation (tDCS) stimulation during language therapy for naming in individuals with chronic aphasia (>6 months post stroke). Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Although the interventions to improve naming can have benefits, a massive number of treatment sessions is usually required to show gains, particularly in individuals with chronic, large LH stroke. tDCS is a promising adjunct to traditional language therapy. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Prior investigators have mainly focused on the role of LH in language recovery, wherein the electrode is placed in the left frontal or temporal region. However, in individuals with large lesions involving key language areas like the frontal and temporal cortex, it may be difficult to find viable tissue to stimulate in the LH. This study uses a novel electrode placement for chronic stroke patients with aphasia with large LH lesions. Targeting the intact right cerebellum allows for the possibility of identifying a single target that can be used across groups of people with aphasia with varying lesion sites and size in the LH. Evidence from functional neuroimaging and clinical studies indicate that the right cerebellum is important for both language and cognitive functions.
The investigators will utilize a randomized, double-blind, sham controlled, within-subject crossover trial design. A random subset (half) of participants will be assigned to the "anode" group (Group Anode) and other half will be assigned to the 'cathode' group (Group Cathode). Participants will take part in 2 intervention periods of 15 computerized naming training sessions (3-5 sessions per week), with either tDCS + naming therapy or sham+ naming therapy, separated by 2 months. Detailed language evaluation will take place before, immediately after, 2 weeks and 2 months post-intervention for each condition. The investigators will test the hypothesis that anodal tDCS or cathodal tDCS over the cerebellum and computerized naming therapy is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computerized naming therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have sustained a left hemisphere stroke.
- •Participants must be fluent speakers of English by self-report.
- •Participants must be capable of giving informed consent or indicating another to provide informed consent.
- •Participants must be age 18 or older.
- •Participants must be premorbidly right handed.
- •Participants must be at least 6 months post stroke.
- •Participants must have an aphasia diagnosis as confirmed by the Boston Diagnostic Aphasia Examination (BDAE) Short Form.
- •Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts
排除标准
- •Participants with lesion involving the right cerebellum
- •Previous neurological or psychiatric disease.
- •Seizures during the previous 12 months.
- •Uncorrected visual loss or hearing loss by self-report.
- •Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
- •Use of N-methyl-D-aspartate receptor (NMDA) antagonists (e.g., memantine).
- •> 80% (140 out of 175) correct responses on the Philadelphia Naming Test at baseline.
- •History of brain surgery or any metal in the head.
- •Scalp sensitivity (per participant report).
结局指标
主要结局
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to Post-treatment
时间窗: Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment.
To determine whether tDCS coupled with computerized naming therapy will improve naming performance of participants with post stroke aphasia more effectively than naming therapy alone (i.e., the sham condition).The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance.
次要结局
- Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Weeks Post-treatment(Pre-treatment and at 2 weeks Post-treatment)
- Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Months Post-treatment(Pre-treatment and at 2 months Post-treatment)
- Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-treatment to Post-treatment(Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment.)
- Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to 2 Months Post-treatment.(Pre-treatment and at 2 months Post-treatment)
- Change in Discourse Ability Pre-treatment to Post-treatment.(Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment)
- Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT)Pre-treatment to 2 Weeks Post-treatment.(Pre-treatment and at 2 weeks Post-treatment)
- Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-Treatment to 2 Week Post-Treatment(Pre-treatment and at 2 weeks Post-treatment)
- Change in Discourse Ability Pre- Treatment to 2 Weeks Post-treatment.(Pre-treatment and at 2 weeks Post-treatment)
- Change in Discourse Ability Pre-treatment to 2 Months Post-treatment.(Pre-treatment and at 2 months Post-treatment)
- Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to Post-treatment(Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment.)
- Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-treatment to 2 Months Post-treatment(Pre-treatment and at 2 months Post-treatment)