NCT05193825: REMOTE

Evaluation of Remote DBS Programming.

Completed NA Last updated 29 August 2025

What this trial tests

NA trial testing Remote Programming in Deep Brain Stimulation in 54 participants. Completed in 30 July 2025.

Timeline

22 March 2022

Primary endpoint
30 December 2024

30 July 2025

Quick facts

Lead sponsor	Thomas Köglsperger
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	22 March 2022
Primary completion	30 December 2024
Estimated completion	30 July 2025
Sites	1 location across Germany

Drugs / interventions tested

• Remote Programming
• Standard Programming

Conditions studied

• Deep Brain Stimulation — all drugs for Deep Brain Stimulation →
• Telemedicine — all drugs for Telemedicine →
• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Thomas Köglsperger

Who can join

Adults 35 to 80, any sex, with Deep Brain Stimulation or Telemedicine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
2. Psychometric reliability of patient-reported visual analogue scales in subthalamic nucleus deep brain stimulation programming for Parkinson's disease.
   Off J, Scherer M, Peschke S, Kirschner A, et al · · 2026 · PMID 41924696 · DOI 10.1093/braincomms/fcag100