Evaluation of a Visual-Analog Scale (VAS) for Remote DBS Programming
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON)
研究概览
简要总结
Deep brain stimulation (DBS) represents the treatment of choice for advanced stages of Parkinson's disease (PD). Currently, adaptive closed-loop stimulation systems that apply disease-specific biomarkers, such as local field potentials (LFPs), are being actively examined to facilitate DBS programming. However, the most suitable feedback signal, still remains to be determined. The investigators previously tested the usefulness of the patient's subjective rating on a visual analogue scale (VAS) as a potential feedback signal for DBS adjustment and found that VAS-based programming lead to similar results as our standard approach. One of the practical advantages of using VAS-based programming strategies - in addition to saving time - is the principal applicability of such an approach to a remote programming setting, although a validation of such an approach is required. Within the scope of a prospective, randomized multicenter clinical trial (the REMOTE Trial), the investigators will examine the effectiveness and safety of VAS-based remote DBS programming in PD by using a novel and recently introduced software platform (Abbott NeurosphereTM Virtual Clinic) that allows for the programming through a smartphone-based video connection with the patient. Therefore, n = 50 PD patients undergoing STN-DBS surgery will be randomized and subsequent to surgery will have their IPG settings adjusted either during regular visits at the hospital or alternatively be programmed remotely through a VAS-based approach. Prior to surgery and after a 90 days follow-up period, we will assess specific clinical (MDS-Unified Parkinson's Disease Rating Scale = UPDRS, Parkinson's Disease Questionnaire-39 sum index = PDQ-39 SI, Beck Depression Inventory = BDI, Montreal Cognitive Assessment Scale = MOCA) parameters to determine the effectivity and safety of the two different strategies on the patient outcome and to correlate it with VAS ratings and MRI data. The results will support the examination of remote-based DBS programming and evaluate the patient's subjective judgment as a valid feedback signal.
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
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and 80 yrs.
- •Ability to communicate with the study physician and to understand the requirements of the study
- •Idiopathic Parkinson's Syndrome; IPS (according to MDS-Criteria)
- •Implantation of a DBS device for the stimulation of the subthalamic nucleus (STN) to treat PD.
排除标准
- •Any inability to communicate with the study physician and to understand the requirements of the study
- •Exclusion criteria of an idiopathic Parkinson's syndrome (IPS)
- •Fulfills the criteria of dementia (according to the International Classification of Diseases (ICD) 10)
研究组 & 干预措施
Group A
Patients in Group A (active comparator) will have their internal pulse generator (IPG) adjusted by conventional procedures, i.e. by regular visits at their caregivers hospital.
干预措施: Standard Programming (Device)
Group B
Patients in Group B (experimental) will have their internal pulse generator (IPG) adjusted by using a novel software (Abbot NeurosphereTM Virtual Clinics) that allows for remote IPG programming and with the aid of a visual analogue scale (VAS).
干预措施: Remote Programming (Device)
结局指标
主要结局
Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON)
时间窗: Assessed at Day 90
Part III of the MDS-Unified Parkinson's Disease Rating Scale (Range 0-128 pts. with high values indicating a more severe disease symptoms)
次要结局
- Change in UPDRS-I(Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes))
- Change in Patient Rating (Patient Diary)(Assessed on a weekly basis by the patient between day +5 and +90 (day 0 = implantation of DBS electrodes))
- Change in UPDRS-II(Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes))
- Change in UPDRS-IV(Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes))
- Change in PDQ-39-SI(Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes))
- Number of visits at the the hospital or remotely(Assessed at day +90 (day 0 = implantation of DBS electrodes))
- Change in TEED(Assessed at day +5 and +90 (day 0 = implantation of DBS electrodes))
研究者
Thomas Köglsperger
Resident Physician; Postdoctoral Research Fellow
Ludwig-Maximilians - University of Munich