Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
NCT ID: NCT06909045
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2026-01-27
2027-02-01
Brief Summary
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\- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?
Researchers will compare aDBS to regular continue deep brain stimulation (cDBS).
Participants will:
* be set up to cDBS during the first programming visit (visit 2);
* be randomized 1:1 to aDBS or cDBS two weeks after visit 2;
* follow-up will be at three and six months after visit 2;
* complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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aDBS group
65 patients with Parkinson's disease will receive adaptive DBS.
Adaptive DBS
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
cDBS group
65 patients with Parkinson's disease will receive continue DBS.
Continue DBS
The Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.
Interventions
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Adaptive DBS
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
Continue DBS
The Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.
Eligibility Criteria
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Inclusion Criteria
* Age older than 18 years;
* Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN;
* Optimal contact point compatible with aDBS in at least one STN;
* Reliable beta peak in at least one STN;
* Able to provide informed consent and comply with the study protocol;
* Understand the Dutch language.
Exclusion Criteria
* Patients with ongoing participation in other clinical trials involving neurological interventions;
* Inability to recognize the difference between the motor ON or OFF state;
* Mild cognitive impairment or dementia;
* Pregnancy.
18 Years
ALL
No
Sponsors
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HagaZiekenhuis
OTHER
Maastricht University Medical Center
OTHER
Universitair Ziekenhuis Leuven
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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dr. Martijn Beudel
Principal Investigator
Principal Investigators
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Martijn Beudel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
Locations
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UZ Leuven
Leuven, , Belgium
Amsterdam UMC
Amsterdam, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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NL009220
Identifier Type: -
Identifier Source: org_study_id
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