Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease (CLOSE-PD)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Parkinson Disease; Deep Brain Stimulation

Treatments: Other: Adaptive DBS; Other: Continue DBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06909045

NL009220

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

aDBS group

Experimental group

Description:

65 patients with Parkinson's disease will receive adaptive DBS.

Treatment:

Other: Adaptive DBS

cDBS group

Active Comparator group

Description:

65 patients with Parkinson's disease will receive continue DBS.

Treatment:

Other: Continue DBS