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Recruiting NCT06909045

Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

No phase Interventional Deep Brain Stimulation Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive DBS, Continue DBS.
Who it may be relevant to
Registry conditions: Deep Brain Stimulation, Parkinson Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

Overview

The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is: \- 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.

Interventions

  • Other Adaptive DBS
    The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
  • Other 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.

Primary outcome measures

  • Home PD diary [Time frame: change from baseline to six months of DBS]
Secondary outcome measures (12)
  • PD Home diary [Time frame: during six months of follow-up]
  • PD Home diary [Time frame: during six months of follow-up]
  • PD Home diary [Time frame: during six months of follow-up]
  • PD Home diary [Time frame: during six months of follow-up]
  • PD Home diary [Time frame: during six months of follow-up]
  • MDS-UPDRS III (ON and OFF phase) [Time frame: change from baseline to six months of DBS]
  • MDS-UPDRS IV [Time frame: change from baseline to six months of DBS]
  • Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase) [Time frame: change from baseline to six months of DBS]
  • Parkinson's Disease Questionnaire 39 (PDQ-39) [Time frame: change from baseline to six months of DBS]
  • Dopaminergic medication usage [Time frame: during six months of follow-up]
  • Montreal Cognitive Assessment (MoCA) [Time frame: change from baseline to six months of DBS]
  • Beck Depression Inventory (BDI) [Time frame: change from baseline to six months of DBS]

Eligibility criteria

Inclusion criteria

  • Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);
  • 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

  • Legally incompetent adults;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 3 centers
  • Amsterdam UMC — Amsterdam
  • Maastricht UMC+ — Maastricht
  • HagaZiekenhuis — The Hague
Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06909045 · NL009220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗