Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Neuropsychological outcomes
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are:
- to evaluate the residual neuroplastic processes in DOC state related to music exposure
- to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation
- to evaluate the impact of this intervention on caregiver's burden and psychological distress.
Participants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.
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, Outcomes Assessor)
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
- •Age > 18 years
- •Post-stroke aphasia
- •Post-stroke neglect
- •Patients with disorders of consciusness (DOC)
排除标准
- •No auditory injury
- •no hystory of neurological disease
- •No hystory of psychiatric disease
- •Previous stroke
- •use of alcohol and drugs
- •premorbid dementia
研究组 & 干预措施
Group 1
Group 1 will receive tEs combined with music stimulation for 2 weeks, 1 week of wash out, then sham stimulation combined with noise (placebo) for other 2 weeks.
干预措施: Combinatory effect of music stimulation and neurostimulation (Other)
Group 2
Group 2 will receive sham stimulation and noise (placebo) for the first 2 weeks, then 1 week wash out, and finally tEs and music stimulation for other 2 weeks.
干预措施: Combinatory effect of music stimulation and neurostimulation (Other)
Group 3
Group 3 will receive only music stimulation and sham stimulation for 2 weeks, 1 week of wash out, then sham stimulation and noise (placebo) for another 2 weeks.
干预措施: Combinatory effect of music stimulation and neurostimulation (Other)
结局指标
主要结局
Neuropsychological outcomes
时间窗: Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks
The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.
Neurophysiological outcome
时间窗: Change from baseline oscillation at 2 weeks and 4 weeks
The ratio of fast (8-30 Hz, α-β) to slow (2-8 Hz, δ-θ) oscillation amplitude at the midline electrodes (Fz, Cz, Pz, Oz) will be measured and compared pre- and post intervention."
Neuropsychological outcomes
时间窗: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks
-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.
Neuropsychological outcomes
时间窗: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks
Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks
Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks
Aachener Aphasie Test (AAT). This test includes six subtests: spontaneous speech, token test, repetition, written language, naming, and comprehension. Spontaneous speech is structured in six parts (0-30). High score means a better performance; Token test is composed by 50 items; for the score the number of error id considered (0-50). Repetition sub test is composed by 50 items; for each item the score range from 0 to 3; high score means better outcome (0-150). Written language subtest is composed by 30 items; for each item the score range from 0 to 3; high score means better outcome (0-90). Naming subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120). Comprehension subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).
Neuropsychological outcomes
时间窗: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks
Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks
Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks
Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks
The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.
Neuropsychological outcomes
时间窗: Change from baseline Barrage Test at 2 weeks and 4 weeks
Barrage test (0-36). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Letter cancellation test at 2 weeks and 4 weeks
Letter cancellation test - (0-104). High score means a better outcome.
Neuropsychological outcomes
时间窗: Change from baseline Sentence reading test at 2 weeks and 4 weeks
Sentence reading test (0-6). High score means a worse outcome.
Neuropsychological outcomes
时间窗: Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks
Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.
次要结局
- Caregiver psychological distress(Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks)
- Caregiver psychological distress(Change from baseline Back depression Inventory II at 2 weeks and 4 weeks)
- Caregiver psychological distress(Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks)
- Caregiver psychological distress(Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks)
- Caregiver psychological distress(Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks)
- Caregiver psychological distress(Change from baseline Family strain questionnaire at 2 weeks and 4 weeks)
研究者
Simona Spaccavento
Principal Investigator
Istituti Clinici Scientifici Maugeri SpA