Treating Primary Progressive Aphasia and Apraxia of Speech With High Definition Transcranial Direct Current Stimulation (HDtDCS-PPA/PAOS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Category Fluency
研究概览
简要总结
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area and left inferior frontal gyrus) thought to aid in memory will improve speech and language difficulties in patients with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). The primary outcome measures are neuropsychological assessments of speech and language functions, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.
详细描述
This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
All patients with a clinical diagnosis of PPA or PAOS will be assigned to either one of the two open-label arms to receive active tDCS. Primary outcome speech and language measures, secondary neuropsychological and electroencephalography (EEG) measures, and pre-screening assessments for study medical history and contraindications for treatment will be collected prior to the treatment (i.e., baseline).
Primary outcome speech and language functions measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and following treatment competition (i.e., 8-week).
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
- None
盲法说明
Study participants will be assigned to either Pre-SMA or LIFG arm.
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
- •18 to 85 years of age
- •A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
- •Capable of understanding and signing an informed consent. Medical information/history, as well as mental status exam and diagnosis provided by referring physician will determine whether or not a caregiver is required to be involved during this process.
排除标准
- •Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator
- •Skull defects
- •A significant history of arrhythmia or epileptic seizures.
- •Not a native English speaker
- •Currently receiving speech-language intervention
- •Unable to communicated verbally
研究组 & 干预措施
Active Pre-SMA tDCS treatment
This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
干预措施: high-definition transcranial direct current stimulation (HD-tDCS) (Device)
Active LIFG tDCS treatment
This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
干预措施: high-definition transcranial direct current stimulation (HD-tDCS) (Device)
结局指标
主要结局
Category Fluency
时间窗: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Evaluation of treatment differences in change on Category Fluency Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
The Boston Naming Test
时间窗: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Evaluation of treatment differences in change on The Boston Naming Test (accuracy and speech latency) Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.
The Controlled Oral Word Association Test
时间窗: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Evaluation of treatment differences in change on the Control Word Association Test Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
The Apraxia battery for Adults - 2 (ABA - 2)
时间窗: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Evaluation of treatment differences in change on characteristics of articulation of the the Apraxia battery for Adults - 2 Dabul, B. L. (2000). Apraxia Battery for Adults (ABA-2) (2nd edn). Austin, TX: ProEd.
Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised
时间窗: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Evaluation of treatment differences in change on Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised Kertesz, Andrew. ( 1982). The Western aphasia battery. New York :Grune \& Stratton.
次要结局
- The Trail Making Test (Part A & B)(Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.)
- The Rey-Osterrieth Complex Figure Test(Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.)
- The Digit Symbol Substitution Test(Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.)
- The Hopkins Verbal Learning Test-Revised(Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.)
- The Digit Span Forward & Backward(Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.)
研究者
John Hart, Jr.
Professor
The University of Texas at Dallas