To document patient outcomes including effectiveness for Boston Scientific Corporation*s VerciseTM CartesiaTM 16-contact Directional Lead (X/HX) with Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson*s Disease (PD).
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
Mean change in MDS-UPDRS III scores from Baseline in meds off condition to 12
weeks post device-activation in stim on/meds off condition.*
*Note: during baseline visit and follow up visits, UPDRS-II and UPDRS-III
assessments will be performed in meds ON and meds OFF condition. The study
subjects will be asked to discontinue anti-Parkinson medication 12 hours before
each visit (or 24 hours before each visit for long acting anti-Parkinson
medication). When the meds OFF assessments are performed, the subject will be
asked to start the anti-Parkinson medication again, after which the meds ON
assessments will take place.
Secondary outcome
Secondary endpoints:
The following secondary endpoints will be analyzed. Study assessments in
parenthesis.
- Mean change in MDS-UPDRS III scores from Baseline (meds off) to 26 weeks and
52 weeks post device-activation (stim on/meds off)
- Mean change in PDQ-39 summary scores from Baseline (meds on) to 12 weeks, 26
weeks and 52 weeks post device-activation (stim on/meds on)
- Mean Change in antiparkinsonian medication use (levodopa equivalents) from
Baseline to 12 weeks, 26 weeks and 52 weeks post device-activation
- Clinical Global Impression of Change (CGI-C) rating score, as assessed by
clinician at 12 weeks, 26 weeks and 52 weeks post device-activation
- Clinical Global Impression of Change - Subject (CGI-C: Sub), as assessed by
subject, at 12 weeks, 26 weeks and 52 weeks post device-activation
Exploratory endpoints:
The following exploratory endpoints will be analyzed. Study assessments in
parenthesis
- Mean change in MDS-UPDRS III scores from Baseline (meds off) up to 5 years
post device-activation (stim on/meds off)
- Mean change in PDQ-39 summary scores from Baseline (meds on) up to 5 years
post device-activation (stim on/meds on)
- Mean Change in antiparkinsonian medication use (levodopa equivalents) from
Baseline up to 5 years post device-activation
- Clinical Global Impression of Change (CGI-C) rating score, as assessed by
clinician up to 5 years post device-activation
- Clinical Global Impression of Change - Subject (CGI-C: Sub), as assessed by
subject up to 5 years post device-activation
- Mean Change in SE scores from Baseline up to 5 years post device-activation
- Mean in MDS-UPDRS scores (Part I, II, III, IV, and total score), from
Baseline (meds on) up to 5 years post device-activation (stim on/meds on)
Safety parameters:
Rates of occurrence of all device hardware, device stimulation and procedure
related non-serious adverse events, all serious adverse events, (regardless of
relationship), and unanticipated serious adverse events through the end of the
study.
Background summary
Parkinson*s disease (PD) is a progressive neurodegenerative disorder that
affects 5.2 million people worldwide. The prevalence of PD is estimated at 0.3%
of the overall population in industrialized countries and advances to 1% by age
60 and 4% in the highest age group.
At present there is no cure for PD; treatment is focused on medical management
of motor symptoms. Medical therapy has been primarily focused on restoring
dopamine levels. Current standards for patient care recommend levodopa as first
line of therapy for the symptomatic control during the early, uncomplicated
stages. Unfortunately, chronic treatment with levodopa frequently leads to
significant side effects.
In the 1990s, high-frequency deep brain stimulation (DBS) was demonstrated to
be effective in reducing the motor complications of subjects with PD . Since
that time, numerous case studies and trials have substantiated these early
findings.
Recent advances in technology including directional stimulation has the
potential to further improve patient outcomes. Several pilot studies have
corroborated the use of directionality and its impact on therapeutic window and
adverse effects.
The directional leads used in this study consist of 16 contacts, the existing
commercially available directional leads have 8 contacts. The 16-contact leads
extend the span of contacts when compared with commercially available
directional leads.
The programming options with the Vercise* Cartesia* 16-contact Directional
Leads potentially improve therapy and/or reduce stimulation-related side
effects are anticipated to be perceived as benefits.
This study will document patient outcomes including effectiveness for Boston
Scientific Corporation*s VerciseTM CartesiaTM 16-contact Directional Lead
(X/HX) with Deep Brain Stimulation Systems for the treatment of Parkinson*s
Disease.
Study objective
To document patient outcomes including effectiveness for Boston Scientific
Corporation*s VerciseTM CartesiaTM 16-contact Directional Lead (X/HX) with Deep
Brain Stimulation (DBS) Systems for the treatment of Parkinson*s Disease (PD).
Study design
Prospective, multi-center, open-label study with an adaptive design.
Intervention
The intervention exists of the implantation of/with the Vercise* Cartesia* X/HX
16-contact Directional Leads, 16-contact Lead Extensions and 16-contact Push
Button OR Cable, instead of commercially available directional leads and
cables.
Study burden and risks
Risks related to the study specific questionnaires:
The study specific outcomes are mainly collected by means of questionnaires and
interviews during routine visits and study specific visits. The questionnaires
and interviews do not pose the subject to any risks, but subjects may find it
difficult, uncomfortable, or tiresome to complete study visits and/or
questionnaires, including discomfort during *meds off* or *meds on* conditions
for testing (UPDRS on 12 weeks, 26 weeks, 2 - 3 - 4 year post activation is not
standard of care).
Risks related to the study specific assessments:
Subjects with postural instability or gait disturbances either due to
Parkinson*s disease or as a side effect of DBS may be at a risk of falling
while walking, rising from a chair, or sitting down in a chair as required for
certain study assessments (UPDRS). The UPDRS is evaluated routinely in meds ON
and meds OFF condition at all protocol time points, subject to the 12 week, 26
week, 2 - 3 - 4 year follow up visit (as these time points are study specific).
The additional risk due to participation to the study is therefore limited.
Risks related to the surgical intervention:
Subjects participating in this study have the same risks for DBS as those who
have DBS for treatment of PD outside of the study. Because the handling
characteristics of the VerciseTM CartesiaTM 16-contact Directional Leads are
similar to those of commercially-available leads, it is expected that the type
and rate of lead-related adverse events will be similar for both kinds of leads.
Risks associated with the study leads / extensions / OR cable:
There are no additional known risks associated with the investigational device
in comparison to commercially-available devices.
Possible interactions with concomitant medical treatments:
While concomitant use of anti-Parkinson medications is being adjusted to fit
the subject*s changed requirements with use of DBS, subjects may experience
symptoms beyond those occurring due to Parkinson*s disease.
In summary, the burden and risks associated with participation to the study are
mainly related to the completion of study specific questionnaires and motor
assessments:
- UPDRS at 12 week, 26 week, 2 - 3 - 4 year follow up
- Completion of questionnaires
In het licht van deze belasting en risico's is het uitvoeren van deze studie
gerechtvaardigd.
Considering the above burden and risks, the conduct of this study is justified.
Vestastraat 6
Kerkrade 6468 EX
NL
Vestastraat 6
Kerkrade 6468 EX
NL
Listed location countries
Age
Inclusion criteria
- 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
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)
- 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.
Design
Recruitment
Medical products/devices used
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 | NCT04577651 |
| CCMO | NL74466.018.20 |