Transcranial Pulse Stimulation: a Potential New Treatment for Chronic Disorders of Consciousness/Cognition Due to Vegetative/Minimally Conscious States and Early Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cognitive improvement
研究概览
简要总结
Alzheimer's Disease (AD) is characterized by the absence of treatments to slow, stop, or reverse its course, with patients finally losing cognitive functions, skills and independence. It is a chronic degenerative disease with high social and medical burden worldwide: AD ranked third among neurological disorders in terms of disability-adjusted life years (DALY) rates.
The primary aim of the research protocol is to improve care for patients with AD, by implementing, with an innovative method, the currently available repertoire of neuromodulation techniques. For this aim, we will investigate whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia.
详细描述
Aims of the project: The primary aim of our research protocol is to improve care for patients with AD by investigating whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia. Additional aims will include the investigation of the neurophysiological profile of patients and the search for a correlation between neuropsychological and neurophysiological data with the serum levels of brain-derived neurotrophic factor (BDNF) and of vascular endothelial growth factor (VEGF).
Materials and Methods
Following a rigorous selection, included patients will be treated through a real/sham structured TPS protocol and followed-up with respect to cognitive improvement, by comparing baseline and follow-up clinical scores. A Double Blind Sham-Controlled Study will be performed: patients will be assigned randomly to receive TPS or sham TPS for 4 weeks in a parallel groups, double-blind study. Patients will receive ether TPS or sham treatment once a day for five days a week for the whole period and will be assessed according to the following schedule: baseline (t0); at two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); at 6 months following the start of TPS (t4). Electroencephalography (EEG) and Somatory Evoked Potentials (SEP) will be contextually recorded in all patients, to compare neurophysiological data of patients treated with real TPS and sham stimulation. Moreover, a serum sample will be collected from patients at baseline, at the end of the stimulation period and at the 6-month follow-up, to compare preprocedural and postprocedural levels of serum BDNF and VEGF.
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)
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
- •diagnosis of early dementia according to current international guidelines
- •disease duration of at least 12 months
- •consent to participate in the study.
排除标准
- •medical instability interfering with standard neurological assessment
- •any contraindication to preliminary MRI for MR-based real-time neuronavigation
- •comorbidities which may interfere with cognitive status
- •any contraindication to Transcranial Pulse Stimulation.
结局指标
主要结局
Cognitive improvement
时间窗: Two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); 6 months following the start of TPS (t4).
Cognitive improvement as evaluated by means of the ADAS-Cog, scores range from 0, that means the absence of cognitive dysfunctions, to a maximum of 70, that indicates a serious deficit in all tests.
次要结局
未报告次要终点
研究者
Francesca Pistoia
Associate Professor of Neurology
ASL 1 Avezzano Sulmona L'Aquila