Study to Evaluate Boston Scientific VerciseTM CartesiaTM 16-contact Directional Lead (X/HX) with Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson*s Disease (PD)
- Conditions
- movement disorderParkinson's disease1002803710009720
- Registration Number
- NL-OMON52786
- Lead Sponsor
- Boston Scientific International BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
- Diagnosis of idiopathic PD with a disease duration of at least 5 years and
presence of at least 2 of the following: resting tremor, rigidity, or
bradykinesia
- 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
- Anti-parkinsonian medications must improve PD symptoms by >= 33%, as measured
by MDS UPDRS-III score
- Mean MDS-UPDRS III score of >=30 in meds off condition
- DRS-2 (Dementia Rating Scale -2) score >= 130 in the meds on condition
- Be willing and able to comply with all visits and study related procedures
(e.g., using the remote control, charging system, etc.).
- Able to understand the study requirements and the treatment procedures and
provides written informed consent before any study-specific tests or procedures
are performed
- At least 18 years of age
- 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)
- Have untreated clinically significant depression per DSM-IV (Diagnostics and
Statistical Manual of Mental Disorders) criteria as determined by BDI-II score
>= 17
- Any current drug or alcohol abuse, as determined by the investigator
- Any history of recurrent or unprovoked seizures
- History of suicidal attempt within the last 1 year prior to consent or
current active suicidal ideation as determined by the investigator
- Any significant medical condition that is likely to interfere with study
procedures or likely to confound evaluation of study endpoints
- Any terminal illness with life expectancy of < 12 months
- A female who is breastfeeding or pregnant (method of assessment per
investigator discretion) at the time of enrollment*, or women who plan to
become pregnant during the course of the study.
- Participation in any other clinical trial (e.g. drug, device, or biologics)
concurrently or within the preceding 30 days. Participation in any other study
will be allowed per investigator/sponsor discretion only
*Pregnancy tests from up to 7 days prior to enrollment in the study will be
accepted.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean change in MDS-UPDRS III scores from Baseline in meds off condition to 12<br /><br>weeks post device-activation in stim on/meds off condition.*<br /><br><br /><br>*Note: during baseline visit and follow up visits, UPDRS-II and UPDRS-III<br /><br>assessments will be performed in meds ON and meds OFF condition. The study<br /><br>subjects will be asked to discontinue anti-Parkinson medication 12 hours before<br /><br>each visit (or 24 hours before each visit for long acting anti-Parkinson<br /><br>medication). When the meds OFF assessments are performed, the subject will be<br /><br>asked to start the anti-Parkinson medication again, after which the meds ON<br /><br>assessments will take place.</p><br>
- Secondary Outcome Measures
Name Time Method