Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Production of Correct Information Units (CIUs) in Cinderella narrative
研究概览
简要总结
Study Design: This is a within-subjects crossover design. Subjects will participate in the procedures twice, once under each condition (active vs. sham stimulation). The order of conditions will be counter-balanced across subjects. Stimulation will target ventral inferior frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome measures will be acquired at the beginning and end of a semester of standard speech-language therapy.
详细描述
Baseline Behavioral Assessment: Medical and neurological history will be taken. Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some of these procedures will be videorecorded for later transcription. Subjects will also complete a pre-tDCS safety screening questionnaire.
tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal electrode will be placed at the following locations (EEG 10-20 system):
(i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)
The cathodal electrode will be placed at the second site:
(ii) over right frontal pole (Fp2)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single, unilateral stroke resulting in aphasia
- •Competency to provide written informed consent
- •Ability to participate in standard aphasia therapy
排除标准
- •Serious psychological condition
- •Serious neurological condition, other than stroke
- •Serious medical condition
- •Pregnancy
- •History of seizures
- •Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator, etc.).
研究组 & 干预措施
A-tDCS & speech-language therapy
Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.
干预措施: Anodal transcranial direct current stimulation (Device)
A-tDCS & speech-language therapy
Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.
干预措施: Speech-language therapy (Behavioral)
Sham-tDCS & speech-language therapy
Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 mA.
干预措施: Sham transcranial direct current stimulation (Device)
Sham-tDCS & speech-language therapy
Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 mA.
干预措施: Speech-language therapy (Behavioral)
结局指标
主要结局
Production of Correct Information Units (CIUs) in Cinderella narrative
时间窗: Following 8 weeks of speech-language therapy
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context
次要结局
- Western Aphasia Battery-Revised (WAB-R)(Following 8 weeks of speech-language therapy)
- Philadelphia Naming Test - Short Form (PNT)(Following 8 weeks of speech-language therapy)
- Communication Activities of Daily Living-2 (CADL-2)(Following 8 weeks of speech-language therapy)
研究者
E. Susan Duncan
Assistant Professor
Louisiana State University and A&M College