Transcranial Direct Current Stimulation to Treat Aphasia: A Superiority Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Naming
研究概览
简要总结
The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
详细描述
This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to give informed consent.
- •Be willing and able to comply with study requirements.
- •Be between 25 and 80 years of age.
- •Have used English as the primary language for > 15 years.
- •Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan.
- •Be greater than 6 months post-stroke.
- •Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score < 9).
- •Correctly name 140 or fewer items on the PNT.
排除标准
- •History of brain surgery except for during the treatment of the acute stroke.
- •Seizures during the previous 12-months.
- •Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection).
- •Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test).
- •Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below.
- •Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators.
- •Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour.
- •Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.
研究组 & 干预措施
2 mA A-tDCS
干预措施: tDCS (Device)
1 mA A-tDCS
干预措施: tDCS (Device)
S-tDCS
干预措施: tDCS (Device)
结局指标
主要结局
Naming
时间窗: From baseline assessment to 4-weeks post treatment
Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment.
次要结局
- Naming(From baseline assessment to 1-week post treatment)
- Naming(From baseline assessment to 24-weeks post treatment)
- Aphasia Severity(From baseline assessment to 4-weeks post treatment)
- Functional Communication(From baseline assessment to 4-weeks post treatment)
- Quality of Life(From baseline assessment to 4-weeks post treatment)
- Communication Confidence(From baseline assessment to 4-weeks post treatment)
- Safety(From baseline assessment to 4-weeks post treatment)
研究者
Leonardo Bonilha
Primary Investigator
University of South Carolina