Evaluation of Remote DBS Programming.

NCT05193825 | Completed DMC FDA Device

• 1 other identifier: Remote DBS Programming
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Brain Stimulation; Telemedicine; Parkinson Disease

Keywords

Deep Brain Stimulation; Telemedicine; Parkinson's Disease (PD); Subthalamic Nucleus (STN); Remote

Outcome Measures

Primary Outcomes (1)

• Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON)

  Part III of the MDS-Unified Parkinson's Disease Rating Scale (Range 0-128 pts. with high values indicating a more severe disease symptoms)

  Assessed at Day 90

Secondary Outcomes (7)

• Change in UPDRS-I

  Assessed at day -1 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)

• 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)

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Device: Standard Programming

Group B

EXPERIMENTAL

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).

Device: Remote Programming

Interventions

Remote Programming DEVICE

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)

Group B

Standard Programming DEVICE

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

Group A

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any inability to communicate with the study physician and to understand the requirements of the study
• Fulfills the criteria of dementia (according to the International Classification of Diseases (ICD) 10)

Sponsors & Collaborators

• Thomas Köglsperger: lead
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• Universitätsklinikum Leipzig: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Muenster: collaborator

Study Sites (1)

Ludwig Maximilian University Hospital

Munich, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician; Postdoctoral Research Fellow

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 18, 2022
• Study Start: March 22, 2022
• Primary Completion: December 30, 2024
• Study Completion: July 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

DE (1)