Evaluation of Remote DBS Programming. (REMOTE)

August 28, 2025 updated by: Thomas Köglsperger

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Ludwig Maximilian University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON)
Time Frame: Assessed at Day 90
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in UPDRS-I
Time Frame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
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
Time Frame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
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
Time Frame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
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
Time Frame: Assessed at day -1 and +90 (day 0 = implantation of DBS electrodes)
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)
Time Frame: Assessed on a weekly basis by the patient between day +5 and +90 (day 0 = implantation of DBS electrodes)
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
Time Frame: Assessed at day +90 (day 0 = implantation of DBS electrodes)
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
Time Frame: Assessed at day +5 and +90 (day 0 = implantation of DBS electrodes)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Köglsperger

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Muenster
Heinrich-Heine University, Duesseldorf
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Leipzig
Friedrich-Alexander-Universität Erlangen-Nürnberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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