Primary Objective: To optimize the current DBS-treatment of advanced PD. For the primary objective the following research questions will be answered: By performing STN DBS under general anesthesia, will there be a significant reduction in cognitive…
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 outcome measures is the number of patients with significant
postoperative cognitive, mood and behavioral adverse effects indicated by a
stringent composite score of >1 within 6 months after STN DBS.
Secondary outcome
Secondary outcome measures are:
- Motor score: MDS-UPDRS
- Clinical Dyskinesia Rating Scale (CDRS)
- Daily functioning: MDS-UPDRS (activities of daily living section), Functional
health status (ALDS)
- Quality of life: PDQ-39
- Treatment satisfaction (See F-vragenlijsten, Treatment satisfaction)
- Burden of therapy (See F-vragenlijsten, Burden of therapy)
- Surgery time, duration of hospital admittance
- PD- medication changes
- Other adverse effects and complications than those registered in the
composite score
- Other psychiatric effects and complications than those registered in the
composite score, measured with: Young Mania Rating Scale, Columbia Suicide
Severity Rating Scale, Hamilton Depression Rating Scale, Hamilton Anxiety
Rating Scale, Starkstein Apathy Rating Scale.
Background summary
Continuous deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an
effective surgical treatment for patients with advanced Parkinson*s disease
(PD) who have severe limitations in functioning despite optimal pharmacologic
treatment. Currently the standard DBS procedure is performed under local
anesthesia. Unfortunately procedure is very burdensome for patients. Due to
advances in modern imaging techniques, it is now possible to visualize the
target nuclei for DBS in the brain directly. Surgery for DBS could therefore
now be performed under general anesthesia. To determine if DBS under general
anesthesia produces less cognitive, affective and behavioural side effects
compared to local anesthesia, a comperative study is warranted.
Study objective
Primary Objective: To optimize the current DBS-treatment of advanced PD. For
the primary objective the following research questions will be answered: By
performing STN DBS under general anesthesia, will there be a significant
reduction in cognitive, mood and behavioral adverse effects when compared to
STN DBS under local anesthesia?
Secondary Objectives: Secondary objectives are to compare motor symptoms (incl.
UPDRS), health related functioning, adverse effects and complications,
psychiatric adverse effects, surgery time, quality of life, patient
satisfaction on the outcome of treatment, and patient evaluation of the burden
of therapy.
Study design
The study will be a single centre prospective randomized open blindend
end-point (PROBE) trial comparing STN DBS under general versus local
anesthesia. A total of 110 patients with advanced Parkinson's disease who are
candidates for deep brain stimulation will be randomized.
Three and five years after the placement of deep brain electrodes, during a
standard of care appointment, the extent of sustained improvement in symptoms
of Parkinson's disesae is measured next to a number of daily functioning and
psychiatric questionnaires are taken.
Intervention
Patients will be randomized to DBS under general anesthesia or DBS under local
anesthesia. As is standard procedure, 2 electrodes will be implanted in the
brain connected to an implanted pulse generator, which will be placed
subcutaneously in the subclavian area.
Study burden and risks
If DBS surgery is perfomed under general anesthesia, this would significantly
lower the risk of experiencing side effects associated with local anesthesia.
Local anesthesia at present is very burdensome for all patients and holds back
some who are actually good candidates for the procedure. DBS under general
anesthesia will have a shorter procedure length. Additionally it will lead to
less postoperative confusion which now adds to the operative burden and this
will shorten hospital admittance as secondary benefit.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years;
- Idiopathic PD with bradykinesia and at least two of the following signs;
resting tremor, rigidity, and asymmetry;
- Despite optimal pharmacological treatment, at least one of the following
symptoms: severe response fluctuations, dyskinesias, painful dystonia or
bradykinesia;
- A life expectancy of at least two years.
Exclusion criteria
- Legally incompetent adults
- Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
- Contraindications for DBS surgery, such as a physical disorder making surgery
hazardous;
- Hoehn and Yahr stage 5 at the best moment during the day;
- Psychosis;
- Current depression;
- No written informed consent;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53375.018.15 |