Randomized trial comparing steered stimulation DBS with ring-shaped DBS for advanced Parkinson’s disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22973

Enrollment

102

Registered

2017-06-23

Start date

2017-12-13

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

Parkinson's Disease Deep Brain Stimulation Subthalamic Nucleus (STN) Steering Ziekte van Parkinson Diepe Hersenstimulatie Nucleus Subthalamicus

Interventions

After a period of searching for the optimal steered mode settings, patients will be randomized to receive both steered and ring-mode stimulation in consecutive periods of two months in random order. T

Eligibility

Inclusion criteria

Inclusion criteria: Age ≥ 18 years bilaterally implanted with the Boston Scientific® Vercise™ system in the STN for idiopathic Parkinson’s Disease at least 6 months previous to study enrollment the optimal ring-mode stimulation setting has been found for the patient: changing settings will either (a) not improve the motor scores or (b) cause stimulation-induced side-effects Patients who have received this system by participating in the GALAXY-trial can only be randomized after completion of the GALAXY trial.

Exclusion criteria

Exclusion criteria: no adequate stimulation response in ring-mode on one of the steerable levels (second and third contact point on each lead) Legally incompetent adults Active psychosis No written informed consent

Design outcomes

Primary

Measure	Time frame
We will evaluate the difference of motor symptoms in patients with steered and ring-mode DBS in standardized OFF-drug phase measured with the Movement Disorders Society Unified Parkinson Disease Rating Scale motor evaluation (MDS-UPDRS-ME).	—

Secondary

Measure	Time frame
Secondary outcome consists of symptom scales, used stimulation settings, medication use, stimulation-induced side-effects, activities of daily living scales and a quality of life questionnaire. At the end of the trial, patients will be asked to choose between the two used programs to evaluate which one was perceived as the best. A sub-analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.	—

Measure

Time frame

Secondary outcome consists of symptom scales, used stimulation settings, medication use, stimulation-induced side-effects, activities of daily living scales and a quality of life questionnaire. At the end of the trial, patients will be asked to choose between the two used programs to evaluate which one was perceived as the best. A sub-analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.

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Contacts

Public ContactT.R. ten Brinke

Kamer H2-225

t.r.tenbrinke@amc.uva.nl020 566 3447

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)