Randomized double-blind multicenter trial comparing bilateral subthalamic nucleus Deep Brain Stimulation (DBS) and bilateral globus pallidus DBS for advanced Parkinson’s disease.

Subthalamic nucleus DBS versus globus pallidus DBS for advanced Parkinson’s disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23721

Enrollment

128

Registered

2006-12-03

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Advanced Parkinson's disease

Interventions

Stereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus.

Eligibility

Inclusion criteria

Inclusion criteria: Idiopathic Parkinson's disease and—despite optimal pharmacological treatment—at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia.

Exclusion criteria

Exclusion criteria: 1. Age below 18 years; 2. Previous functional stereotactic neurosurgery; 3. Hoehn and Yahr stage 5 at the best moment during the day; 4. A Mattis dementia rating scale score of less than 120; 5. Psychosis, and contraindications for stereotactic neurosurgery such as a physical disorder making surgery hazardous (severe hypertension, blood coagulation disorder, severe dysphagia, or dysphasia).

Design outcomes

Primary

Measure	Time frame
The primary outcome measures are the number of patients with significant cognitive, mood, and behavioral adverse effects and the off-on phase weighted AMC Linear Disability Scale (functional improvement). Significant cognitive, mood, and behavioral adverse effects are defined as worsening on three or more cognitive tests (based on the reliable change index), or the loss of professional activity/work/job, or the loss of an important relationship (e.g. marriage), or psychosis/depression/anxiety for a period of 3 months or longer. Outcome measurements will be performed at baseline and 12 months after surgery.	—

Measure

Time frame

The primary outcome measures are the number of patients with significant cognitive, mood, and behavioral adverse effects and the off-on phase weighted AMC Linear Disability Scale (functional improvement). Significant cognitive, mood, and behavioral adverse effects are defined as worsening on three or more cognitive tests (based on the reliable change index), or the loss of professional activity/work/job, or the loss of an important relationship (e.g. marriage), or psychosis/depression/anxiety for a period of 3 months or longer. Outcome measurements will be performed at baseline and 12 months after surgery.

—

Secondary

Measure	Time frame
Secondary outcome consists of symptom scales (UPDRS motor, CDRS), activities of daily living scales (ALDS and UPDRS ADL), a quality of life questionnaire (PDQL), adverse effects, and medication use. Additionally, patients will undergo extensive neuropsychological and standardized psychiatric assessment.	—

Contacts

Public ContactRob M.A. Bie, de

Academic Medical Center (AMC), Department of Neurology, H2-236, P.O. Box 22660

r.m.debie@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)