In this pilot study, we aim to assess practical feasibility, technical feasibility and safety of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on patient-specific sweet…
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
The primary endpoints are safety (occurrence of stimulation induced
side-effects, duration of induced side effects (temporary or permanent),
severity of the stimulation induced side-effects) and technical feasibility
(time from surgery to DBS-initiation, time from surgery to reaching optimal DBS
stimulation settings) of the computational workflow.
Secondary outcome
The secundary endpoints are the practical feasibility of a larger randomized
trial (inclusion rate of patients meeting the inclusion criteria,
withdrawal/drop-out within the study period, adherence to the research protocol
with regard to the DBS programming), difference in UPDRS-III OFF-medication
condition before surgery and UPDRS-III OFF-medication ON-stimulation condition
at 3, 6 and 12-months follow-up between the two arms, difference in Levodopa
Equivalent Daily Dose (LEDD) before surgery and at 3, 6 and 12-months follow-up
between the two arms, difference in Parkinson Disease Questionnaire-39 (PDQ-39)
before surgery and at 3, 6 and 12-months follow-up between the two arms, number
of hospital consultations (by phone or as an outpatient) during the follow-up
period.
Background summary
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a
well-accepted treatment for advanced Parkinson*s disease (PD). Currently
programming of the DBS is done in a trial-and-error manner and it can take up
to 12 months to reach optimal stimulation parameters of the DBS. Technological
advances in electrode design and implantable pulse generator (IPG) capabilities
lead to an almost infinite number of stimulation options. To explore the
potential benefit of all these technological advances, a conventional
trial-and-error approach is no longer sufficient. Consequently, there is a
clear need for a more computational approach of programming DBS systems. This
pilot study is a prospective trial to proof that the concept of programming
bilateral STN-DBS for PD in a computational fashion based on disease phenotype
and brain connectivity is feasible.
Study objective
In this pilot study, we aim to assess practical feasibility, technical
feasibility and safety of a computational approach for programming newly
implanted STN-DBS patients with PD. This computational approach will be based
on patient-specific sweet spots and connectivity of the STN. The results of
this pilot study will be used to create a practically feasible computational
approach for DBS programming to use in a larger randomized study in the future.
Study design
Prospective randomized pilot study.
Intervention
Patients will be randomized to receive either (i) computational DBS programming
(n=12) or (ii) conventional trial-and-error based DBS programming (n=12).
Study burden and risks
We hypothesize that the proposed computational approach for DBS-programming
provides PD patients with a non-inferior motor outcome compared to the
conventional workflow, but that the optimal DBS settings will be reached faster
using the computational based approach. All participants will need to undergo
an additional head CT scan, compared to the conventional workflow arm. The risk
of the additional head CT in this patient population is negligible. Therefore,
we estimate that the additional risk for patients who participate in this study
is negligible.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
o Patients that are eligible for bilateral STN-DBS surgery for idiopathic PD in
the Radboud university medical center
o Patients are implanted with Boston Scientific Cartesia directional leads.
o Patients have given written informed consent to participate in the study
Exclusion criteria
o Any significant medical condition that is likely to interfere with study
procedures.
o Participation in any other clinical trial (e.g. drug, device, or biologics)
concurrently or within the preceding 30 days.
o Lead orientation cannot be determined by GuideXT algorithm based on the new
head-CT scan.
Design
Recruitment
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 | NL87334.091.24 |