Evaluation of Remote DBS Programming. (REMOTE)

Thomas Köglsperger

Status: Active, not recruiting

Conditions: Parkinson Disease; Deep Brain Stimulation; Telemedicine

Treatments: Device: Standard Programming; Device: Remote Programming

Study type: Interventional

Funder types: Other

Identifiers

NCT05193825

Remote DBS Programming

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Device: Standard Programming

Group B

Experimental group

Description:

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).

Treatment:

Device: Remote Programming