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…
Bron
Verkorte titel
Aandoening
Parkinson's Disease (PD)/ Ziekte van Parkinson
Deep Brain Stimulation (DBS)/ Diepe hersenstimulatie
Stereotaxy/ Stereotaxie
Subthalamic Nucleus (STN)/ Nucleus Subthalamicus
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measures is a composite score of the postoperative cognitive, mood and behavioral adverse effects.
Achtergrond van het onderzoek
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 cognitive, mood and behavioral 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
Doel van het onderzoek
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
Onderzoeksopzet
1. Baseline (screening)
2. Surgery
3. Day one/two after surgery
4. Two weeks after surgery
5. Six Months after surgery
Onderzoeksproduct en/of interventie
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.
Publiek
Rozemarije Holewijn
Locatie AMC
Amsterdam
The Netherlands
020 566 3542
r.a.holewijn@amsterdamumc.nl
Wetenschappelijk
Rozemarije Holewijn
Locatie AMC
Amsterdam
The Netherlands
020 566 3542
r.a.holewijn@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5513 |
NTR-old | NTR5809 |
CCMO | NL53375.018.15 |