Evaluation of Remote DBS Programming.

NCT ID: NCT05193825

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2025-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Programming

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Remote Programming

Intervention Type: 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)

Interventions

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)

Intervention Type: 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.

Intervention Type: DEVICE

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
• Fulfills the criteria of dementia (according to the International Classification of Diseases (ICD) 10)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role: collaborator

Universitätsklinikum Leipzig

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: collaborator

Thomas Köglsperger

OTHER

Sponsor Role: lead

Responsible Party

Thomas Köglsperger

Resident Physician; Postdoctoral Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ludwig Maximilian University Hospital

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

Remote DBS Programming

Identifier Type: -

Identifier Source: org_study_id