Evaluation of Remote DBS Programming. (REMOTE)

Evaluation of a Visual-Analog Scale (VAS) for Remote DBS Programming

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Telemedicine; Deep Brain Stimulation
• Intervention / Treatment: Device: Standard Programming; Device: Remote Programming

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Ludwig Maximilian University Hospital
      • Contact: Thomas Köglsperger, MD; Phone Number: +49440043106; Email: thomas.koeglsperger@med.uni-muenchen.de.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UPDRS-I	Part I of the MDS-Parkinson's Disease Rating Scale (Range 0-52 pts. with high values indicating more severe disease symptoms)	Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
Change in UPDRS-II	Part II of the MDS-Parkinson's Disease Rating Scale (Range 0-52 pts. with high values indicating more severe disease symptoms)	Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
Change in UPDRS-IV	Part IV of the MDS-Parkinson's Disease Rating Scale (Range 0-24 pts. with high values indicating more severe disease symptoms)	Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
Change in PDQ-39-SI	Parkinson's Disease Questionnaire-39 Sum Index (Range 0-100 pts. with high values indicating more severe disease symptoms)	Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
Change in Patient Rating (Patient Diary)	Number of hours spent with bothersome dyskinesia or in a reduced mobility state (OFF)	Assessed on a weekly basis by the patient between day +5 and +90 (day 0 = implantation of DBS electrodes)
Number of visits at the the hospital or remotely	Number of doctor-patient contacts either in person at the hospital (Group A) or remotely (Group B)	Assessed at day +90 (day 0 = implantation of DBS electrodes)
Change in TEED	Total Electrical Energy Delivered by the IPG; TEED (1s) = (voltage2 × frequency × pulsewidth) / impedance (1s)	Assessed at day +5 and +90 (day 0 = implantation of DBS electrodes)

Collaborators and Investigators

• Sponsor: Thomas Köglsperger
• Collaborators: University Hospital Muenster; Heinrich-Heine University, Duesseldorf; University Hospital Tuebingen; Universitätsklinikum Hamburg-Eppendorf; Universitätsklinikum Leipzig; Friedrich-Alexander-Universität Erlangen-Nürnberg; Paracelsus Hospital Zwickau

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Deep Brain Stimulation; Subthalamic Nucleus (STN); Remote; Parkinson's Disease (PD)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Remote DBS Programming

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes