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

Not Applicable

Not yet recruiting

• Conditions: Deep Brain Stimulation; Parkinson Disease

• Registration Number: NCT06909045
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Study Start: 2025-06-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Home PD diary	change from baseline to six months of DBS	The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window

Secondary Outcome Measures

Name	Time	Method
PD Home diary	during six months of follow-up	ON time without troublesome dyskinesia
MDS-UPDRS III (ON and OFF phase)	change from baseline to six months of DBS	Motor symptoms
MDS-UPDRS IV	change from baseline to six months of DBS	Motor complication including motor fluctuations and dyskinesias
Academic Medical Center Linear Disability Score (ALDS)	change from baseline to six months of DBS	Level of physical disability
Parkinson's Disease Questionnaire 39 (PDQ-39)	change from baseline to six months of DBS	Quality of life
Dopaminergic medication usage	during six months of follow-up
Montreal Cognitive Assessment (MoCA)	change from baseline to six months of DBS	MoCA is a cognitive screening tool for detecting and scoring cognitive impairment
Beck Depression Inventory (BDI)	change from baseline to six months of DBS	Mood status
Starkstein Apathy Scale (SAS)	change from baseline to six months of DBS	Apathy status
Side effects	during six months of follow-up	Number and sort of side effects
Time of DBS titration	during six months of follow-up	Duration of DBS titration based on the number and duration of hospital visits
Assessor's evaluation of the ease of programming	after six months of follow-up	Five-point Likert scale
Beta oscillatory activity	during six months of follow-up	Amount of decrease of oscillatory activity in the beta range
DBS settings (1)	during six months of follow-up	Electrical energy consumption expressed by the Total electrical energy delivered (TEED)
DBS settings (2)	during six months of follow-up	DBS amplitudes in mA
DBS settings (3)	during six months of follow-up	Average stimulation fraction expressed as percentages
Parkinson's Disease Sleep Scale (PDSS-2)	during six months of follow-up	Sleep disturbances and quality of sleep
LFP characteristics (2)	during six months of follow-up	Beta volatility expressed as a.u.
Participant's evaluation of the burden of the treatment	after six months of follow-up	Five-point Likert scale
Participant's satisfaction on the outcome of treatment	after six months of follow-up	Five-point Likert scale

Trial Locations

Locations (3)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

HagaZiekenhuis; 🇳🇱 Den Haag, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands