Clinical trial NCT06909045: Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Official title: Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Brain Stimulation
Parkinson Disease
Keywords: adaptive DBS
continue DBS
aDBS
cDBS
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: HagaZiekenhuis
name: Maastricht University Medical Center
First posted: 2025-04-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 randomized 1:1 to aDBS or cDBS;
* follow-up will be six months;
* complete PD Home diary at baseline, two months, four months and at six months.


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;
* 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.

Primary outcomes:
measure: Home PD diary
timeFrame: change from baseline to six months of DBS
Secondary outcomes:
measure: PD Home diary
timeFrame: during six months of follow-up
measure: MDS-UPDRS III (ON and OFF phase)
timeFrame: change from baseline to six months of DBS
measure: MDS-UPDRS IV
timeFrame: change from baseline to six months of DBS
measure: Academic Medical Center Linear Disability Score (ALDS)
timeFrame: change from baseline to six months of DBS
measure: Parkinson's Disease Questionnaire 39 (PDQ-39)
timeFrame: change from baseline to six months of DBS
measure: Dopaminergic medication usage
timeFrame: during six months of follow-up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: change from baseline to six months of DBS
measure: Beck Depression Inventory (BDI)
timeFrame: change from baseline to six months of DBS
measure: Starkstein Apathy Scale (SAS)
timeFrame: change from baseline to six months of DBS
measure: Side effects
timeFrame: during six months of follow-up
measure: Time of DBS titration
timeFrame: during six months of follow-up
measure: Assessor's evaluation of the ease of programming
timeFrame: after six months of follow-up
measure: Beta oscillatory activity
timeFrame: during six months of follow-up
measure: DBS settings (1)
timeFrame: during six months of follow-up
measure: DBS settings (2)
timeFrame: during six months of follow-up
measure: DBS settings (3)
timeFrame: during six months of follow-up
measure: Parkinson's Disease Sleep Scale (PDSS-2)
timeFrame: during six months of follow-up
measure: LFP characteristics (2)
timeFrame: during six months of follow-up
measure: LFP characteristics (2)
timeFrame: during six months of follow-up
measure: Participant's evaluation of the burden of the treatment
timeFrame: after six months of follow-up
measure: Participant's satisfaction on the outcome of treatment
timeFrame: after six months of follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
affiliation: Amsterdam UMC
name: Martijn Beudel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: