NCT04577651Completed
Cartesia eXTend 3D Study
Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 26 Sept 2020
- Start date
- 2 Nov 2020
- Primary completion date
- 27 Feb 2023
- Lead sponsor
- Boston Scientific Corporation
- Diseases
- Parkinson disease
- NCT number
- NCT04577651
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 2 Nov 2020 to the primary completion date, 27 Feb 2023
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any current drug or alcohol abuse, as determined by the investigator
Other illness
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery
- Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
- Any history of recurrent or unprovoked seizures
Who the study is looking for
- Candidate for DBS implant in the treatment of Parkinson's disease
- Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
- Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
- Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Berlin, Charite Virchow Standort, Wedding Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Uniklinik Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitaetsklinikum Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Universitaetsklinikum Tuebingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitaetsklinikum Wuerzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| St Georges Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMC St Radboud Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.