The GALAXY study: General Anesthesia versus Local Anesthesia in StereotaXY for Deep Brain Stimulation in Parkinson*s disease, a randomized controlled trial.

Completed

• Conditions: Parkinson's disease; primary parkinsonism; shaking palsy; 10028037; 10009720

• Registration Number: NL-OMON47557
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures is the number of patients with significant<br /><br>postoperative cognitive, mood and behavioral adverse effects indicated by a<br /><br>stringent composite score of >1 within 6 months after STN DBS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are:<br /><br>- Motor score: MDS-UPDRS<br /><br>- Clinical Dyskinesia Rating Scale (CDRS)<br /><br>- Daily functioning: MDS-UPDRS (activities of daily living section), Functional<br /><br>health status (ALDS)<br /><br>- Quality of life: PDQ-39<br /><br>- Treatment satisfaction (See F-vragenlijsten, Treatment satisfaction)<br /><br>- Burden of therapy (See F-vragenlijsten, Burden of therapy)<br /><br>- Surgery time, duration of hospital admittance<br /><br>- PD- medication changes<br /><br>- Other adverse effects and complications than those registered in the<br /><br>composite score<br /><br>- Other psychiatric effects and complications than those registered in the<br /><br>composite score, measured with: Young Mania Rating Scale, Columbia Suicide<br /><br>Severity Rating Scale, Hamilton Depression Rating Scale, Hamilton Anxiety<br /><br>Rating Scale, Starkstein Apathy Rating Scale.</p><br>