Can Transcranial Direct Stimulation Enhance the Efficacy of a Rehabilitative Intervention for the Treatment of Freezing of Gait in Parkinson's Disease? A Double Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Walking parcours
研究概览
简要总结
Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and responds often incompletely to conventional therapy. The pathogenesis remains largely unknown and therapeutic alternatives are needed. Rehabilitative interventions that consist of learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent the most efficacious intervention, but difficulties in learning and execution of these cognitive strategies are the main cause of failure. Transcranial direct current stimulation (tDCS) enhances motor task learning and execution in patients with PD and might enhance the efficacy of rehabilitative interventions.
This study intends to address the following question whether tDCS can enhance the efficacy of rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 30 to 80 years with DOPA-responsive PD Hoehn and Yahr (HY) grade of 2 to 4 while "off"
- •must be on a regimen including levodopa
- •total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
- •Gait difficulties with Freezing of Gait as defined by MDS-UPDRS I score ≥ 2 in FOG
- •Optimal conventional PD medication for > 1 month prior to screening
- •scheduled for rehabilitative intervention for the treatment of freezing of gait
排除标准
- •significant concurrent medical or psychiatric disease
- •history of seizures and epilepsy
- •Dementia or other neurodegenerative disease (besides PD)
- •pallidotomy, implanted electrodes and generator for deep brain stimulation
- •pregnancy
- •surgically or traumatically implanted foreign bodies such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tDCS.
- •Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
- •significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 meters.
- •presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MOCA) <20 or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview).
- •presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
- •presence of clinically significant hallucinations
- •participation in any rehabilitation therapy for FOG within the last six months prior to screening
研究组 & 干预措施
Active tDCS
Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
干预措施: Rehabilitation Therapy (Behavioral)
Active tDCS
Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
干预措施: Active tDCS (Device)
Sham tDCS
Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
干预措施: Sham tDCS (Device)
Sham tDCS
Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
干预措施: Rehabilitation Therapy (Behavioral)
结局指标
主要结局
Walking parcours
时间窗: from baseline to one month follow-up
This standardized parcours, performed under guidance of a physiotherapist, includes real-life conditions which are known to precipitate freezing. Time needed to perform the parcours and number of FOG episodes will be assessed.
次要结局
- 39-Item Parkinson's Disease Questionnaire (PDQ-39)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
- New Freezing of Gait Questionnaire (N-FOGQ)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
- 10 Meter Walk Test (10MWT)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
- Timed Up & GO (TUG)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
- Beck Depression Inventory (BDI)(from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention))
研究者
David Benninger, MD
MD
Centre Hospitalier Universitaire Vaudois