Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- functional walking ability
研究概览
简要总结
Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.
StimuLOOP.PD-Sleep intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigators will conduct a proof-of-concept study to investigate a sleep intervention tailored to the individual patient in the context of motor rehabilitation.
• Targeted auditory stimulation during sleep (TASS): The investigators aim to reactive rehabilitation-related memories through presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands.
The investigators will leverage TASS to enhance consolidation of the movement patterns that are learned during rehabilitation.
The investigators expect that this intervention will lead to greater gains in functional walking ability and balance. Beyond demonstrating a proof-of-concept for novel methods of applying TASS stimulation in the context of neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of TASS with a rehabilitation.
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
- •Idiopathic Parkinson's disease with gait and postural stability deficits
- •≥18 years of age
- •UPDRS III gait scores 1-3
- •UPDRS III postural instability scores 1-3
- •Prescribed rehabilitation therapy
- •Informed consent as documented by signature
- •Adjustments in dopaminergic medication and DBS stimulation to improve
排除标准
- •Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20
- •Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
- •History of a physical or neurological condition that interferes with study procedures
- •Social and/or personal circumstances that interfere with the ability to return for assessments
- •Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
- •Recent DBS implant (≤ 6 months)
- •Inability to perform outcome assessments without walking aid
- •Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)
研究组 & 干预措施
Sham arm
Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention)
干预措施: TASS Intervention (Sham) (Other)
Verum arm
Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention)
干预措施: TASS Intervention (Verum) (Other)
结局指标
主要结局
functional walking ability
时间窗: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
the change in functional walking ability assessed with the 6-minute walk test (6MWT)
postural stability
时间窗: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
the change in postural stability assessed with the MiniBEST test measured before and after the intervention period.
次要结局
- Continuous Relative Phase(Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).)
- Phase Coordination Index(Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).)
- Variability(Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).)
- Symmetry(Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).)
- Margin of Stability(Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).)