Clinical trial NCT05193825: Evaluation of Remote DBS Programming.
Official title: Evaluation of a Visual-Analog Scale (VAS) for Remote DBS Programming
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deep Brain Stimulation
Telemedicine
Parkinson Disease
Keywords: Deep Brain Stimulation
Telemedicine
Parkinson's Disease (PD)
Subthalamic Nucleus (STN)
Remote
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Universitätsklinikum Leipzig
name: Heinrich-Heine University, Duesseldorf
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital Muenster
First posted: 2022-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON)
timeFrame: Assessed at Day 90
Secondary outcomes:
measure: Change in UPDRS-I
timeFrame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
measure: Change in UPDRS-II
timeFrame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
measure: Change in UPDRS-IV
timeFrame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
measure: Change in PDQ-39-SI
timeFrame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
measure: Change in Patient Rating (Patient Diary)
timeFrame: Assessed on a weekly basis by the patient between day +5 and +90 (day 0 = implantation of DBS electrodes)
measure: Number of visits at the the hospital or remotely
timeFrame: Assessed at day +90 (day 0 = implantation of DBS electrodes)
measure: Change in TEED
timeFrame: Assessed at day +5 and +90 (day 0 = implantation of DBS electrodes)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University Hospital
state: Bavaria
Study officials:
References: