The aim of the study is to show safety and effectiveness of the Sapiens electrode in an acute, intra-operative setting.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To confirm that stimulation through the Sapiens lead is safe and able to
produce equivalent effects as stimulation through currently available
commercial DBS leads.
Secondary outcome
2) To establish that steering stimulation with the Sapiens lead modulates the
threshold for stimulation-induced effects as found in *ring mode* through the
same Sapiens lead
Background summary
Stimulation performed through the currently used large annular electrodes may
induce side-effects by stimulating adjacent structures, along with the target
nucleus. By selectively activating part of the 32 electrodes on the Sapiens
lead, stimulation can be precisely steered towards the targeted areas, sparing
other structures.
Selective stimulation can minimize the simultaneous involvement of adjacent
structures. This is expected to increase the threshold for stimulation-induced
side-effects, while leaving the threshold for therapeutic benefit unchanged.
This improvement of the so-called "therapeutic window" will make it easier to
obtain and maintain an effective clinical benefit. Moreover, the Sapiens lead
will be also able to reproduce the same field of stimulation - and stimulation
effects - of the currently available electrode, so that it could be used in
exactly the same way if needed.
Study objective
The aim of the study is to show safety and effectiveness of the Sapiens
electrode in an acute, intra-operative setting.
Study design
The study is a single-center, single-group, performance and safety study,
conducted acutely during regular DBS surgery with an observational period of
two months following surgery.
Intervention
NA
Study burden and risks
The FAME study may give direct benefit to the individual study participants and
to the group of (future) patients eligible for DBS as a whole:
Individual benefit
Test stimulation with an acute electrode is part of the common DBS procedure to
determine the optimal location for the chronic lead placement. Stimulation with
the Sapiens lead is anticipated to confirm the selected location for the
chronic DBS lead. However, in situations where use of the Sapiens lead
indicates that the chronic DBS position could be optimized further in relation
to what is achieved with the routine surgical targeting technique - at the
discretion of the surgical team - this additional information could be taken
into account to refine placement of the chronic commercial DBS lead.
Group benefit
The knowledge coming from this study will be used for the optimization and
realization of a new stimulation device (Sapiens lead and stimulating system).
This new device has an innovative lead which carries many potential advantages
with respect to the currently available devices. In particular, the possibility
of efficaciously steering stimulation would help decrease the incidence and
severity of side effects associated with chronic deep brain stimulation, thus
improving the therapeutic window. A better therapeutic window may result in a
more effective and long-lasting stimulation therapy for future generation of
patients undergoing DBS therapy.
Conclusion
Individual benefits to patients participating in the study are limited since
the novel Sapiens lead will be used only in the acute setting. The potential
individual patient benefits amounts to a confirmation of the target determined
by routine procedure or an improved targeting for the chronic commercial DBS
system.
Potential benefits for future patients eligible to DBS are the improved
therapeutic window of the DBS therapy owing to the novel Sapiens lead design.
The versatility in tuning the stimulation settings with the new Sapiens lead
may reduce the incidence of stimulation-induced side-effects and may increase
the therapeutic window available for chronic DBS.
Therefore, it is concluded that the benefits of the FAME study outweigh the
risks associated with the study.
High Tech Campus 48-16
Eindhoven 5656 AE
NL
High Tech Campus 48-16
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
• Diagnosis of idiopathic Parkinson*s disease
• Clinical indication for STN DBS with MER.
• Age > 18 years
• Subject is a male or non-pregnant female
• Ability to comply with the study assignments.
• Ability to give informed consent.
Exclusion criteria
• Parkinson*s disease graded according to Hoehn and Yahr stage 5
• Score on MATTIS dementia rating scale <120
• Psychiatric contraindications to STN DBS
• General contraindications for stereotactic surgery and general anaesthesia (e.g. severe hypertension, blood coagulation disorder)
• Subject has factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use or history of hemorrhagic stroke, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
• Subject has a diagnosis of acute myocardial infarction or cardiac arrest less than or equal to 6 months prior to the screening testing.
• Subject has a history of a seizure disorder.
• Subject requires short surgery time due to general health issues, as determined by the investigator.
• Subject is a woman who is pregnant or planning to become pregnant, or a woman of child-bearing potential, who is not using a medically-acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to the investigational procedure visit.
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 |
|---|---|
| CCMO | NL40206.018.12 |