Neurostimulation for the Treatment of Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- QVITI S.A.
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Percentage score in the Naming Task (trained words)
研究概览
简要总结
The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.
详细描述
There are about 15 million strokes worldwide each year. Of this group, about 30% suffer from aphasia. Aphasia is a speech-language disorder associated with exceptional difficulty performing daily communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years.
Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding.
In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia.
To boost the effects of aphasia rehabilitation, effective brain stimulation protocol still needs to be developed.
Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, investigator and outcomes assessor are all blinded. Designated research team members will be unblinded in order to manage computerized procedure.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements.
- •Inclusion Criteria:
- •diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
- •presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
- •chronic stage of the disease - time since the stroke occurred over 6 months.
- •ability to achieve an accuracy in the Naming Task of 10-60%.
- •18-80 years
- •right-handedness before the stroke.
- •ability to give informed written consent.
- •fluency in English.
排除标准
- •severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
- •presence of metal implants in the skull.
- •presence of major untreated or unstable psychiatric disease.
- •history of epilepsy or seizures.
- •ongoing medication that increases the risk of epileptic seizures.
- •presence in the body of cardiac stimulator, pacemaker or vagus nerve stimulator (implanted).
- •history of speech, language, hearing, or intellectual disability during childhood.
- •pregnancy (based on declarations)
- •Exclusion criteria during the trial:
- •high intolerance to stimulation.
- •occurrence of an epileptic seizure.
- •other previously absent neurological or mental symptoms
- •Withdrawal criteria:
- •high intolerance to stimulation (participants experience severe discomfort during stimulation);
- •occurrence of an epileptic seizure;
- •other previously absent neurological, physical or mental symptoms.
研究组 & 干预措施
Real tACS
tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.
干预措施: tACS (Device)
Sham tACS
tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.
干预措施: tACS (Device)
结局指标
主要结局
Percentage score in the Naming Task (trained words)
时间窗: 12-week follow-up
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
次要结局
- Percentage score in the Naming Task (trained words)(immediately after the intervention and 6-week follow-up)
- Number of correct answers without supporting cues(during treatment sessions)
- Accuracy of naming during the therapy session(during treatment sessions)
- Percentage Score in Naming Task (untrained words)(immediately after the intervention, 6-week and 12-week follow-up)
- Communication Effectiveness Index (CETI)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- Boston Diagnostic Aphasia Examination (BDAE)(pre-treatment, 12-week follow-up)
- Accuracy of masking measurement: Patient and Researcher(the end of the last treatment session)
- Visual Analog Scale (VAS)(before and after each treatment session/during the treatment)
- Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- General Health Questionnaire (GHQ-12)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- Brief Resilience Scale (BRS)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- BDNF genotype(pre-treatment)