Evaluation of Remote DBS Programming.

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.

Conditions

• Deep Brain Stimulation
• Telemedicine
• Parkinson Disease

Interventions

DEVICE

Remote Programming

Patients in the experimental group (Group B) will have their internal pulse generators (IPGs) adjusted through a novel software that allows for remote DBS programming (NeurosphereTM Virtual Clinic)

DEVICE

Standard Programming

Patients in the active comparator group (Group A) will have their internal pulse generators (IPGs) adjusted through a standard procedure at their caregivers institution.

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg

  collaborator OTHER

• Universitätsklinikum Leipzig

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• Thomas Köglsperger

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-22

Primary Completion

2024-12-30

Completion

2025-07-30

FDA Device

Yes

Countries

• Germany

Study Locations