Vercise DBS Dystonia Registry
Research type
Research Study
Full title
Registry of Deep Brain Stimulation with the VERCISE™ System for treatment of Dystonia: Vercise DBS Dystonia Registry
IRAS ID
178915
Contact name
Yen Tai
Contact email
Sponsor organisation
Boston Scientific
Duration of Study in the UK
6 years, 7 months, 31 days
Research summary
VERCISE DBS Dystonia Registry is a postmarket observational registry of on label use of the Boston Scientific Corporation’s (BSC) VerciseTM Deep Brain Stimulation (DBS) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
The Registry involve patients who will undergo an implantation of the BSC VerciseTM DBS system as part of their standard clinical management and as per routine care, enabling evaluation of health economic, safety aspects
and patient clinical outcomes assessed in a "real-life" environment.
Prior the procedure patients will be invited in order to collect Baseline information. And following the implant procedure, the patients will participate in this study for about 3 years and will be required to make approximately 8 study related visits. At follow up visits, patients will be expected to complete questionnaires related to their symptoms. In addition to the study related visits, patients may need to see the study doctor for additional visits as a part of standard
of care.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0293
Date of REC Opinion
20 Jul 2015
REC opinion
Further Information Favourable Opinion