In 2013 the Boston Scientific VERCISE System has obtained regulatory approval for use in the European Union, CE mark was granted for the treatment of intractable primary and secondary dystonia.The objective of the study is to compile characteristics…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical endpoints:
The following clinical endpoints will be analyzed for each sub-group of
dystonia separately (Primary vs. Secondary):
• Proportion of subjects with 30% or greater reduction in Baseline BFMDRS or
TWSTRS score at 26 weeks, 52 weeks, 2 years, and 3 years post implant procedure
• Change in BFMDRS scores from Baseline to 26 weeks, 52 weeks, 2 years, and 3
years post implant procedure
• Change in TWSTRS scores from Baseline to 26 weeks, 52 weeks, 2 years, and 3
years post implant procedure
• Change in SF-36v2 score (SF-10v2 in patients under the age of 18 years at the
time of consent) from Baseline to 26 weeks, 52 weeks, 2 years, and 3 years post
implant procedure
• Change in GDS scores from Baseline to 26 weeks, 52 weeks, 2 years, and 3
years post implant procedure
• Clinical Global Impression of Change (CGI-C) rating score, as assessed by
neurologist, at 26 weeks, 52 weeks, 2 years, and 3 years post implant procedure
• Clinical Global Impression of Change - Subject (CGI-C: Sub), as assessed by
subject, at 26 weeks, 52 weeks, 2 years, and 3 years post implant procedure
• Clinical Global Impression of Change - Caregiver (CGI-C: Crg), as assessed by
caregiver, at 26 weeks, 52 weeks, 2 years, and 3 years post implant procedure
Secondary outcome
Safety parameters:
Rates of occurrence of all serious adverse events (SAEs) and all adverse device
effects (ADEs), including serious adverse device effects (SADEs) and
unanticipated serious adverse device effects (USADEs) at 3 years post implant
procedure
Heatlh economics endpoints:
• Total cost of treatment and resource utilization from Baseline through end of
study (RUI)
• Change in economic value from Baseline to 26 weeks, 52 weeks, 2 years and 3
years post implant procedure
Background summary
Dystonia is a neurological condition characterized by involuntary movements and
muscle spasm. Dystonia is an umbrella term covering a broad spectrum of
conditions, which can be classified depending on the cause, body areas affected
and age of onset of the dystonia. Idiopathic dystonia is estimated to be the
third most frequent movement disorder after essential tremor and Parkinson's
disease.
Typically the initial treatment consists of medical therapy and injections of
muscle relaxing medications. In the past, for subjects who experienced reduced
response to the medical therapy, often surgical procedures were performed
creating irreversible lesions in the brain.
Due to the introduction of reversible and more patient specific adjustable
treatments, such as deep brain stimulation, these surgical procedures are now
considered less advantageous.
Since the 2000s, the safety and efficacy of deep brain stimulation for the
treatment of dystonia has been demonstrated repeatedly by randomized clinical
trials and case studies. The current registry will follow a large group of
patients who were implanted according to the standard of care for 3 years.
Study objective
In 2013 the Boston Scientific VERCISE System has obtained regulatory approval
for use in the European Union, CE mark was granted for the treatment of
intractable primary and secondary dystonia.
The objective of the study is to compile characteristics of real-world
outcomes, economic value and technical performance of Boston Scientific
Corporation's commercially approved VERCISE deep brain stimulation system, when
used according to applicable Directions for Use.
Study design
Prospective, on-label, multi-center, international study. Study of a CE marked
device within the approved indications.
Study burden and risks
Subjects who take part in this study are subject to similar risks shared by all
subjects who receive this stimulator but are not participating to this study.
In addition, this study is set up to collect data through questionnaires and
interviews. The questionnaires and interviews will take place during routinely
scheduled follow up visits but they are, depending from study center to study
center, not always routinely taken. Because of participation to the study, the
follow up visits will take additional time as compared to routine care, which
could be uncomfortable to the subject.
Green Square - Lambroekstraat 5D
Diegem 1831
BE
Green Square - Lambroekstraat 5D
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
-Subject meets criteria established in the locally applicable VERCISE System
Directions for Use (DFU) for dystonia
-Subject is at least 7 years old. Parent or guardian consent is required in
patients who are younger than 18 years at the time of consent
Exclusion criteria
Subject meets any contraindication in the VERCISE System locally applicable
Directions for Use
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02686125 |
| CCMO | NL70665.058.19 |