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
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."
次要结局
- Caregiver psychological distress(Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks)
研究者
Simona Spaccavento
Principal Investigator
Istituti Clinici Scientifici Maugeri SpA