|- candidate number||24293|
|- NTR Number||NTR5809|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-apr-2016|
|- Secondary IDs||NL53375.018.15 MEC AMC|
|- Public Title||GALAXY (General Anesthesia vs. Local Anesthesia in stereotaXY) study|
|- Scientific Title||The GALAXY study: General Anesthesia versus Local Anesthesia in Stereotaxy for Deep Brain Stimulation in Parkinsons disease: a randomized controlled trial
|- hypothesis||We hypothesize that performing DBS under general anesthesia will (1) further improve outcome by lessening postoperative cognitive, mood and behavioral adverse effects, (2) shorten surgery time and hospital admittance, and (3) produce comparable symptomatic and functional improvement as surgery under local anesthesia |
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease, Deep Brain Stimulation (DBS), Stereotaxy, Subthalamic Nucleus (STN)|
|- 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;
No written informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2016|
|- planned closingdate||1-nov-2018|
|- Target number of participants||110|
|- Interventions||Patients will be randomized to DBS under general anesthesia or DBS under local anesthesia. For DBS, two electrodes will be implanted in the brain connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area.|
|- Primary outcome||The primary outcome measures is a composite score of the postoperative cognitive, mood and behavioral adverse effects. |
|- Secondary outcome||The secondary outcome measures consist of motor symptoms, adverse effects and complications, surgery time, functional health, quality of life, patient satisfaction on the outcome of treatment, patient evaluation of the burden of therapy, and medication |
|- Timepoints||1. Baseline (screening)|
3. Day one/two after surgery
4. Two weeks after surgery
5. Six Months after surgery
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Rozemarije Holewijn|
|- CONTACT for SCIENTIFIC QUERIES|| Rozemarije Holewijn|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Currently the standard DBS procedure is performed under local anesthesia. Unfortunately the procedure is very burdensome for patients. Due to advances in modern imaging techniques, it is now possible to visualize the DBS-target directly. Surgery for DBS could therefore be performed under general anesthesia.
The objective is to demonstrate that STN DBS for PD under general anesthesia will reduce neuropsychological adverse effects.
The study will be a single center prospective randomized open label blinded endpoint (PROBE) trial comparing STN DBS under general versus local anesthesia. A total of 110 patients with advanced PD who are candidates for DBS will be randomized.
The primary outcome measures is a composite score of the postoperative cognitive, mood and behavioral adverse effects.
The secondary outcome measures consist of motor symptoms, adverse effects and complications, surgery time, functional health, quality of life, patient satisfaction on the outcome of treatment, patient evaluation of the burden of therapy, and medication
Countries of recruitment: The Netherlands
|- Main changes (audit trail)|
|- RECORD||23-apr-2016 - 19-jun-2016|