Randomized trial comparing steered Deep Brain Stimulation with ring-shaped Deep Brain Stimulation for advanced Parkinson*s disease

Randomized trial comparing steered Deep Brain Stimulation with ring-shaped Deep Brain Stimulation for advanced Parkinson*s disease - STEEred vs RING-mode DBS for Parkinson*s disease (STEERING) trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53065

Enrollment

Registered

2017-08-25

Start date

2017-12-13

Completion date

Unknown

Last updated

2025-12-01

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

Conditions

Parkinson Parkinson's disease

Interventions

After a period of searching for the optimal steered mode settings, patients will be randomized and blindly receive two different programming forms of DBS stimulation: ring mode and steered mode duri

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years bilaterally implanted with the Boston Scientific or Medtronic 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
The primary outcome measure is a score of motor symptoms in daily living as expressed in the Movement Disorders Society Unified Parkinson Disease Rating (MDS-UPDRS) motor evaluation in standardized OFF-drug phase. This score is measured in the total of all patients included, the subgroup of patients whose ring-mode stimulation has yielded a suboptimal effect (as evaluated by the patients* physician) and the subgroup of patients whose ring-mode stimulation has yielded a good effect (as evaluated by the patients* physician).The combined subgroups form the total of all included patients.	—

Measure

Time frame

The primary outcome measure is a score of motor symptoms in daily living as expressed in the Movement Disorders Society Unified Parkinson Disease Rating (MDS-UPDRS) motor evaluation in standardized OFF-drug phase. This score is measured in the total of all patients included, the subgroup of patients whose ring-mode stimulation has yielded a suboptimal effect (as evaluated by the patients* physician) and the subgroup of patients whose ring-mode stimulation has yielded a good effect (as evaluated by the patients* physician).The combined subgroups form the total of all included patients.

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Secondary

Measure	Time frame
Secondary outcome consists of symptom scales, percentage of patients with great symptom improvement (an MDS-UPDRS score in OFF-phase of 30% or greater), 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, percentage of patients with great symptom improvement (an MDS-UPDRS score in OFF-phase of 30% or greater), 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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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)