Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- EEG coherence analysis
研究概览
简要总结
The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and
- •Age between 18 and 65 years.
- •Time from the lesion: more than 4 months.
- •Stable clinical condition.
- •written consent fron the legal administrator of the patient.
排除标准
- •Presence of epileptiform activity on EEG.
- •Previous history of epilepsy.
- •Extensive hemorrhage or ischemia.
- •Metallic clips or intracranial implants.
- •Pacemaker e Baclofen infusion.
- •Presence of drugs influencing arousal or awareness.
研究组 & 干预措施
Brain stimulation
Brain stimulation will consist of 4 types of intervention:
- real transcranial direct current stimulation (two weeks, five days a week)
- a week of wash-out
- Sham transcranial direct current stimulation (two weeks, five days a week)
- two weeks of wash-out
- real repetitive transcranial magnetic stimulation (two weeks, four days a week)
- a week of wash-out
- Sham repetitive transcranial magnetic stimulation (two weeks, three days a week)
Stimulations will be counterbalanced between patients.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Brain stimulation
Brain stimulation will consist of 4 types of intervention:
- real transcranial direct current stimulation (two weeks, five days a week)
- a week of wash-out
- Sham transcranial direct current stimulation (two weeks, five days a week)
- two weeks of wash-out
- real repetitive transcranial magnetic stimulation (two weeks, four days a week)
- a week of wash-out
- Sham repetitive transcranial magnetic stimulation (two weeks, three days a week)
Stimulations will be counterbalanced between patients.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Brain stimulation
Brain stimulation will consist of 4 types of intervention:
- real transcranial direct current stimulation (two weeks, five days a week)
- a week of wash-out
- Sham transcranial direct current stimulation (two weeks, five days a week)
- two weeks of wash-out
- real repetitive transcranial magnetic stimulation (two weeks, four days a week)
- a week of wash-out
- Sham repetitive transcranial magnetic stimulation (two weeks, three days a week)
Stimulations will be counterbalanced between patients.
干预措施: Transcranial Direct Current Stimulation (SHAM) (Device)
Brain stimulation
Brain stimulation will consist of 4 types of intervention:
- real transcranial direct current stimulation (two weeks, five days a week)
- a week of wash-out
- Sham transcranial direct current stimulation (two weeks, five days a week)
- two weeks of wash-out
- real repetitive transcranial magnetic stimulation (two weeks, four days a week)
- a week of wash-out
- Sham repetitive transcranial magnetic stimulation (two weeks, three days a week)
Stimulations will be counterbalanced between patients.
干预措施: Repetitive Transcranial Magnetic Stimulation (SHAM) (Device)
结局指标
主要结局
EEG coherence analysis
时间窗: Change from baseline EEG coherence at the end of brain stimulation (two weeks)
EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level.
次要结局
- Disability Rating Scale(Change from baseline DRS scale at the end of brain stimulation (two weeks))
研究者
Marianna Cavinato
PhD
IRCCS San Camillo, Venezia, Italy