Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Tailored SCS programming
研究概览
简要总结
Balance and gait impairment increases the risk of falls and contributes to a reduced quality of life and shorter survival in Parkinson disease (PD) and atypical Parkinsonism patients. In preliminary case studies, electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which stimulation settings produce the best clinical response for mobility and gait, and achieving these results chronically are all significant unmet needs. Using quantitative laboratory and mobile technologies to test a range of stimulation settings, this research study aims to determine which SCS parameters or combination of parameters is best suited to effectively alleviate disabling symptoms experienced by each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting male and female participants, aged 18 years to 80 years
- •Idiopathic PD with II-IV Hoehn-Yahn stage
- •A history of frequent falls, gait and balance dysfunction and postural instability
- •ON-freezing
- •Ability to perform a gait/walking task (under close supervision),
- •PD participants referred by Dr. Jog to the functional neurosurgeon for SCS implantation for treatment of their gait and balance dysfunction and/or for their freezing of gait.
- •SCS eligibility has been confirmed by neurologist and neurosurgeon
- •Patients who receive SCS for their gait and mobility must participate in this study in order to determine which SCS parameters provide the patient with the best outcome for their PD symptoms.
- •able to give informed consent
- •Able to attend all clinic visits and assessments
- •No dementia or psychiatric abnormalities on neuropsychological testing
- •No significant secondary causes (such as cerebrovascular disease, normal pressure hydrocephalus, peripheral neuropathy, severe degenerative lower limb or back disease).
- •we had a few devices to include exploratory trial in atypical PD (MSA, PSP, and CBD confirmed diagnosis from clinic).
排除标准
- •History of stroke
- •History of ALS or Myasthenia Gravis
- •Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
- •Persons prescribed zonisamide
- •Women reporting that they are pregnant
- •Persons medically unstable with contraindications to SCS will be excluded
- •Previous brain surgery or cardiac pacemaker
- •Eligibility for deep brain stimulation surgery
- •Moderately severe parkinsonism in the context of unstable pharmacological treatment
- •Dementia as assessed by DSM criteria or severe cognitive disturbances
- •Severe psychiatric symptoms (in particular, hallucinations and depression)
- •Bad general health
- •Lack of compliance at follow-up
- •Severe dyskinesias
- •Significant cognitive impairment
结局指标
主要结局
Tailored SCS programming
时间窗: 3 weeks
Participants following SCS implantation will undergo 3 programming visits. 9 SCS programs will be tested in a repeated fashion on separate days and at different times of the day (morning vs afternoon). The SCS setting(s) to produce the best motor (gait) response will be used by the participant in-home. SCS device will not be used during this time period.
Changes in spatiotemporal gait measures using objective gait analysis
时间窗: 12 months
Spatiotemporal gait parameters known to be affected in parkinsonian syndromes will be analyzed over a 12 month period using gait analysis software. Best SCS setting tailored to each participant's gait symptoms will be assessed at 3-, 6- and 12-months time-points.
次要结局
- Changes in ABC scores(12 months)
- Changes in PDQ-39 scores(12 months)
- Changes in NFOG-Q scores(12 months)
- DaTscan imaging(12-months)
- Changes in UPDRS-III scores(12 months)
- Changes in QoL scores(12 months)
- Proprioception testing(12-months)