Cartesia eXTend 3D (A4092)
Research type
Research Study
Full title
Study to Evaluate Boston Scientific Vercise(TM) Cartesia(TM) 16-contact Directional Lead (X/HX) with Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson’s Disease (PD)
IRAS ID
285656
Contact name
Francesca Morgante
Contact email
Sponsor organisation
Boston Scientific International S.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
The study is a multi-centre study designed to collect data related to improvement in Parkinson’s Disease symptoms and overall impact to quality of life including activities of daily living etc.
Patients who meet study eligibility criteria will receive a DBS Directional Lead (Vercise Cartesia) that is capable of providing stimulation (or electric current) to the targeted area in the brain connected to a Vercise Genus Stimulator System. Post-implant, they will return to the clinic for evaluation on a regular basis up to 5 years. The success of the study is based on their improvement in motor function at 3 months follow up as compared to Baseline. A total of estimated 125 subjects who will receive treatment/device activated is expected in the study.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0930
Date of REC Opinion
9 Sep 2020
REC opinion
Further Information Favourable Opinion