Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
研究概览
简要总结
In the last decades, the research in neuroimaging-informed stroke prognosis and treatment has had a little clinical impact, often because of the costs of bringing complex procedures to the bedside. Cerebral stroke remains the leading cause of disability, with 65% of survivors chronically impaired at 6 months. Gamma synchrony (GS) is a fundamental mechanism of cortical function and can be estimated and modulated in a simple, inexpensive, and reliable way. It has provided valuable and cost-effective guidance in several neuropsychiatric conditions. In previous studies, we developed simple yet robust methods for assessing and manipulating GS and proved its relationship with clinical impairment in preliminary data.
The aim of the present project is to predict and improve stroke recovery by leveraging cortical mapping and modulation of GS via transcranial alternating current stimulation (tACS), a safe and inexpensive technique. The project capitalizes on technology readily available to the Italian national health system.
详细描述
The project will consist of 3 Work Packages (WPs):
- The aim of WP1 is to map the relationship between GS and clinical outcomes with EEG.
- The aim of WP2 is to translate GS assessment and modulation to bedside.
- The aim of WP3 is to modulate GS to improve rehabilitation outcomes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants in this study will be 140 stroke patients rehabilitated at IRCCS San Camillo hospital. 80 will participate in the WP1 and the WP2, while 60 will participate in the WP3 study. In WP1, data will also be collected on 80 healthy volunteer participants, approximately the same age as the patients.
- •Inclusion Criteria (healthy participants)
- •- no neurological or psychiatric disorder
- •Inclusion Criteria (patients)
- •right or left hemisphere damage
- •unilateral stroke
- •no comorbidities with psychiatric disorders
排除标准
- •Diagnosis of epilepsy or family history up to the second degree with it
- •Episodes of febrile convulsions or recurrent fainting
- •Head trauma
- •Presence of surgical clips or metal implants in the head
- •Diagnosis of heart disease
- •Presence of a cardiac pacemaker or artificial heart valve
- •Presence of hearing aids/prostheses
- •Hearing problems or tinnitus
- •Vision problems not corrected with lenses (such as color blindness)
- •Taking tricyclic antidepressant medications
- •Taking neuroleptic medications
- •Diagnosis of headache or migraine
结局指标
主要结局
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
时间窗: immediately after the intervention
Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 1 (WP1)
时间窗: immediately after the intervention
Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 3 (WP3)
时间窗: immediately after the intervention
Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
次要结局
- Behavioral performance (accuracy). Work Package 1 (WP1)(immediately after the intervention)
- Behavioral performance (response times). Work Package 1 (WP1)(immediately after the intervention)
- Behavioral performance (response times). Work Package 3 (WP3)(immediately after the intervention)
- Behavioral performance (accuracy). Work Package 3 (WP3)(immediately after the intervention)