Multimodal Neuromodulation in Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- NeuroCom Sensory Organization Test (SOT)
研究概览
简要总结
Multimodal non-invasive neuromodulation paired with physical therapy is a promising treatment modality for Parkinson's Disease ("PD"), however the optimal stimulation method, dose, and associated therapeutic protocol for long-lasting clinical benefits have not yet been identified for this population.
Here the investigators aim to develop and execute a preliminary clinical study exploring the potential benefits of multimodal non-invasive neuromodulation. The therapeutic intervention will involve translingual neurostimulation +/- galvanic neurostimulation, paired with an intensive physical and cognitive therapy program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Galvanic stimulation is masked (sham vs active)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of idiopathic PD
- •Disease staging between II and III (mild to moderate), according to the modified Hoehn and Yahr scale;
- •Currently taking prescribed antiparkinsonian medication regularly with:
- •No medication changes in the last 30 days
- •Responsive to oral dopamine replacement therapy
- •Score higher than 24, verified through the Montreal Cognitive Assessment
- •Must demonstrate moderate burden of motor symptoms (MDS-UPDRS part II >12 and MDS-UPDRS part III scores >35) 34
- •Must be able to voluntarily give written (or verbal) informed consent
- •Must have ability to reliably use the devices
- •Must be able to understand and complete all assessments (provided in English only)
排除标准
- •Diagnosis of atypical parkinsonism;
- •History of epilepsy
- •Presence of an implanted electrical device
- •Previous surgical intervention for PD (DBS implantation - deep brain stimulation);
- •Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy)
- •Presence of severe freezing episodes.
- •Women who are pregnant or nursing
- •History of unstable mood disorder or unstable anxiety disorder or psychosis
- •Those with a recent history of substance abuse and/or dependence (alcohol or other drugs)
- •Have been diagnosed with neurological disease other than Parkinson's disease.
- •Have a major concomitant illness or illnesses including cancer or disease of the cardiovascular, respiratory and/or renal systems deemed significant medical risk in the opinion of the principle investigator
- •Have a diagnosed vestibular dysfunction
- •Have had eye surgery within the previous three months or ear surgery within the previous six months
- •Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial
- •Contraindicated for PoNS, including:
- •Current disease or sensitivity of the oral cavity 25.
- •History of oral cancer 25.
- •Oral surgery within three months of screening 25.
- •Oral cavity piercings that could interfere with PoNSTM use 25.
- •Sensitivity to Nickel, Copper, or Gold 25.
- •Currently enrolled in a PoNSTM treatment program or use of the PoNSTM device in the last 5 weeks 25.
- •History of penetrating brain injuries 25.
- •Chronic infectious disease 25.
- •Unmanaged hypertension 25.
- •Diabetes 25.
- •History of seizures
- •Contraindicated for GVS, including:
- •Metallic brain implant(s) 26.
- •Brain surgery within the past six months 26.
- •Highly sensitive skin behind the ears
结局指标
主要结局
NeuroCom Sensory Organization Test (SOT)
时间窗: Baseline to week 4
Composite balance score
NeuroCom Limits of Stability test (LOS)
时间窗: Baseline to week 4
Postural stability score
NeuroCom Adaptation Test
时间窗: Baseline to week 4
Adaptation score
MiniBESTest
时间窗: Baseline to week 4
Balance score
次要结局
- Electroencephalography - latencies(Baseline to week 4)
- Electroencephalography - amplitudes(Baseline to week 4)
- Unified Parkinson's Disease Rating Scale(Baseline to week 4)
- Montreal Cognitive Assessment (MoCA)(Baseline to week 4)
研究者
Ryan D'Arcy
Principal Investigator
HealthTech Connex Inc.