Clinical trial NCT04577651: Cartesia eXTend 3D Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.

Eligibility criteria: Key Inclusion Criteria:

* 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.).

Key Exclusion Criteria:

* 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 current drug or alcohol abuse, as determined by the investigator
* Any history of recurrent or unprovoked seizures

Primary outcomes:
measure: Change in Motor Function
timeFrame: 12 weeks post device-activation
Secondary outcomes:
measure: Change in Motor Function
timeFrame: 26 weeks post device-activation
measure: Change in Motor Function
timeFrame: 52 weeks post device-activation
measure: Change in Quality of Life
timeFrame: 12 weeks post device-activation
measure: Change in Quality of Life
timeFrame: 26 weeks post device-activation
measure: Change in Quality of Life
timeFrame: 52 weeks post device-activation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow Standort, Wedding
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Koeln
country: Germany
facility: Uniklinik Koeln
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: