NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Change from baseline in verbal fluency on the Verbal fluency test at 1 and 30 days after completion of the treatment period
研究概览
简要总结
The current standard of care for rehabilitation of patients with aphasia after stroke is conventional speech and language therapy (SLT). Due to economic realities on most stroke units, SLT can often not be given with optimal intensity in the first weeks after the stroke. Developing new adjuvant therapies which may render SLT sessions more effective is thus one approach to improve rehabilitation outcome. Recent functional imaging studies in post-stroke aphasia have shown that the recruitment of brain regions in the unaffected hemisphere seems to be an inferior strategy for recovery of language function as compared to re-activation of brain regions in the vicinity of the infarct. Non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) are new methods to modulate brain activity. Evidence from our own feasibility study in sub-acute stroke suggests that these new techniques, when applied in conjunction with conventional SLT, may help to normalize brain activation patterns and might yield better rehabilitation outcome than SLT alone. With NORTHSTAR, we propose a multicenter proof-of-concept study to investigate the safety, feasibility and efficacy of these new non-invasive brain stimulation methods as adjuvant therapies for subacute post-stroke aphasia.
Our goal is to determine the most effective brain stimulation modality to decrease inhibition onto the left side of the brain. We will assess if a combination of brain stimulation and speech and language therapy will improve language recovery. We will quantify language recovery (expressive and comprehensive skills) using specific tests, commonly used by speech and language therapists.
We will invite patients recently admitted to the stroke unit of the study centers to participate in our research project. Once patients consent to our study we will randomly assign them to one of three experimental groups. For 12 days, all groups of patients will be setup with brain stimulation during their usual rehabilitation sessions. Two of those groups (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS), in the third group, patients will not receive real stimulation (placebo group). By comparing the extent of aphasia recovery between groups, we will determine the benefits attributable to brain stimulation relative to SLT alone.
详细描述
Aim 1: To test the hypothesis that any type of non-invasive brain stimulation in combination with conventional SLT results in better aphasia recovery at 1 and 30 days after end of treatment than SLT with sham stimulation.
Aim 2: To test the hypothesis that tDCS in combination with SLT is non-inferior to rTMS in combination with SLT but both are superior to SLT with sham stimulation.
Aim 3: To test the hypothesis that there will be no difference in the frequency of adverse events between the treatment groups.
Aim 4: To test the hypothesis that there is a differential influence of attention, time to treatment, infarct location and bilingualism on the treatment effect.
Aim 5: To test the hypothesis that the extent of functional and structural connectivity between the stimulation site over the triangular part of the right inferior frontal gyrus and the left hemisphere primary language centers determines effectiveness of the therapy.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic stroke in the left MCA territory
- •between 5 and 30 days post stroke
- •right-handedness
- •English, French or German as language of daily use
- •score below the lower limit of the norm on at least one of the primary outcome measures
排除标准
- •prior symptomatic ischemic or hemorrhagic stroke
- •severe comprehension deficit that may compromise informed consent or understanding of instructions
- •contraindications to MRI and/or TMS/tDCS
- •neurodegenerative or psychiatric disease
- •epilepsy or EEG-documented epileptic discharges
- •chronic renal or liver failure
- •life-threatening diseases
- •auditory or visual deficits that cannot be corrected and might impair testing
结局指标
主要结局
Change from baseline in verbal fluency on the Verbal fluency test at 1 and 30 days after completion of the treatment period
时间窗: at baseline, 1 and 30 days after completion of the treatment period
Verbal fluency test
Cumulative number of Adverse Events and Serious Adverse Events during 10 days of therapy
时间窗: at each days of treatment
Cumulative number of Adverse Effects and Serious Adverse Effects during 10 days of therapy
Change from baseline in language comprehension on the Token test at 1 and 30 days after completion of the treatment period
时间窗: at baseline, 1 and 30 days after completion of the treatment period
Token test
Change from baseline in naming ability on the Boston naming test at 1 and 30 days after completion of the treatment period
时间窗: at baseline, 1 and 30 days after completion of the treatment period
Boston Naming Test
Cumulative number of Adverse Events and Serious Adverse Events during 30 days following completion of the treatment
时间窗: at each day during 30 days following completion of the treatment
Cumulative number of Adverse Events and Serious Adverse Events during 30 days following completion of the treatment
次要结局
- Change from baseline in Aphasia global test scores on standard aphasia test batteries at 1 and 30 days after completion of the treatment period(at baseline, 1 and 30 days after completion of the treatment period)
研究者
Dr. Alexander Thiel
Alexander Thiel, MD, Associate Professor.
Thiel, Alexander, M.D.