Deep Brain StimulationREMOTENCT05193825
Evaluation of Remote DBS Programming.
A study testing Remote Programming and Standard Programming in people with Deep Brain Stimulation and Telemedicine, run by Thomas Köglsperger at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Deep Brain Stimulation, Telemedicine, Parkinson Disease
- What is being tested?
- Remote Programming and Standard Programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Deep Brain Stimulation, Telemedicine, Parkinson Disease
- Being tested
- Remote Programming, Standard Programming
- Keywords
- Deep Brain Stimulation, Telemedicine, Parkinson's Disease (PD), Subthalamic Nucleus (STN), Remote
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ProgrammingDevice
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)
Standard ProgrammingDevice
Patients in the active comparator group (Group A) will have their internal pulse generators (IPGs) adjusted through a standard procedure at their caregivers institution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Remote Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Assessed at Day 90
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Assessed at day +5 and +90 (day 0 = implantation of DBS electrodes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start22 Mar 2022
- Primary completion30 Dec 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Köglsperger
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Leipzig, Heinrich-Heine University, Duesseldorf, Universitätsklinikum Hamburg-Eppendorf, University Hospital Muenster
- Responsible party
- Sponsor-investigator, Thomas Köglsperger, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193825
- Sponsor's protocol ID
- Remote DBS Programming
- Acronym
- REMOTE
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Visual-Analog Scale (VAS) for Remote DBS Programming
- ClinicalTrials.gov ID
- NCT05193825
- Acronym / sponsor ID
- REMOTE / Remote DBS Programming
- Conditions
- Deep Brain Stimulation, Telemedicine, Parkinson Disease
- Keywords
- Deep Brain Stimulation, Telemedicine, Parkinson's Disease (PD), Subthalamic Nucleus (STN), Remote
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Thomas KöglspergerUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Leipzig, Heinrich-Heine University, Duesseldorf, Universitätsklinikum Hamburg-Eppendorf, University Hospital Muenster
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Standard ProgrammingPatients 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 B | Experimental | Device: Remote ProgrammingPatients 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). |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ProgrammingPatients 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) | Device | Group B |
| Standard ProgrammingPatients in the active comparator group (Group A) will have their internal pulse generators (IPGs) adjusted through a standard procedure at their caregivers institution. | Device | Group A |
Primary outcome
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)
7 secondary outcomes
Change in UPDRS-I
Time frame: 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)
Change in UPDRS-IV
Time frame: 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)
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 visits at the the hospital or remotely
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Programming and Standard Programming in people with Deep Brain Stimulation and Telemedicine, run by Thomas Köglsperger at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UPDRS-III (Stimulation ON/Medication ON = STIM-ON/MED-ON) (time frame: Assessed at Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.