Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline to 3-month follow up in verbal fluency task
研究概览
简要总结
This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC).
详细描述
Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no effective treatment is available, non-invasive brain stimulation techniques, such as tDCS, could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous activity of the neural network by applying a direct current flow on the cortical brain areas (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and behavioral symptoms.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomization, monitoring and data management will be performed locally. Randomization will be performed using an online list randomizer (random.org). The study coordinator will generate the random allocation sequence before enrollment. Then, one sub-investigator will perform clinical evaluations and another one will administer the treatment.
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et al., 2017);
- •Age > 40 and < 89 years;
- •Presence of a caregiver supportive the patient for all study procedure;
- •Ability to walk for at least 5 steps either independently or with a minimum support (another patients holding patient's arm or with a walker)
排除标准
- •Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS)
- •Difficult in understanding Italian language
- •Presence of severe sensory deficits (for example, visual or hearing impairments)
- •Education level <5 years
- •History of drug abuse
- •History of severe psychiatric disorders
- •History of transient ischemic attacks
- •Cortical or sub-cortical vascular lesions
- •Seizures or severe heart problems and previous neurosurgical operations
- •Absence of subjective cognitive deficits
- •MMSE (Mini-Mental State Examination) score <20
- •Left-handedness
结局指标
主要结局
Change from baseline to 3-month follow up in verbal fluency task
时间窗: Baseline (T0); At 3-month (T3)
fluency in verbal names
次要结局
- Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)(Baseline (T0); At 3-month (T3))
- Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)(Baseline (T0); At 3-month (T3))
- Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)(Baseline (T0); At 3-month (T3))
- Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)(Baseline (T0); At 3-month (T3))
- Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)(Baseline (T0); At 3-month (T3))
- Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)(Baseline (T0); At 3-month (T3))
研究者
Marina Picillo
Clinical Professor
University of Salerno