Improving Aphasia Outcomes Through tDCS-Mediated Attention Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Language Specific Attention Treatment Probe
研究概览
简要总结
Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.
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
- Double (Participant, Care Provider)
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
- •18 years or older.
- •No diagnosis of neurological disorder (other than stroke).
- •No diagnosis of psychiatric disorder.
- •No seizure within the past 6 months.
- •Not pregnant.
- •In chronic phase of recovery, defined as at least 6 months post-stroke.
- •Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
- •No metal implants in the head.
- •No unhealed skull fractures.
- •Onset of aphasia related to left hemisphere stroke.
- •Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
- •Mild to moderate aphasia.
- •Cognitive ability minimally within functional limits.
- •Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
- •Willing to allow audio-recording of study sessions.
排除标准
- •Younger than 18 years old.
- •Diagnosis or history of neurological disorder other than stroke.
- •Diagnosis or history of psychiatric disorder.
- •History of seizures within the past 6 months.
- •<6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
- •Currently undergoing speech and language therapy targeting auditory comprehension or attention.
- •Metal implants in the head.
- •Currently has a skull fracture.
- •Onset of aphasia related to etiology other than left hemisphere stroke.
- •Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
- •No aphasia or severe aphasia.
- •Cognitive ability below functional limits.
- •Unable to pass vision and/or hearing screening with use of corrective aids.
- •Unwilling to allow audio-recording of study sessions.
研究组 & 干预措施
Active transcranial direct current stimulation (tDCS) paired with speech-language therapy
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
干预措施: Active transcranial direct current stimulation (tDCS) (Device)
Active transcranial direct current stimulation (tDCS) paired with speech-language therapy
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
干预措施: Language Specific Attention Treatment (Behavioral)
Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
干预措施: Sham transcranial direct current stimulation (tDCS) (Device)
Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
干预措施: Language Specific Attention Treatment (Behavioral)
结局指标
主要结局
Language Specific Attention Treatment Probe
时间窗: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment.
次要结局
- Continuous Performance Test(Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline)
- Attention Network Test(Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline)
- Scenario Test(Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline)
- Revised Token Test(Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline)