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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47557

Enrollment

110

Registered

2016-02-17

Start date

2016-05-23

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease primary parkinsonism shaking palsy

Interventions

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 gener

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)