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NCT Number: NCT06909045

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

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.

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Key information

Conditions

Deep Brain Stimulation Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive DBS

Other

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

Continue DBS

Other

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 outcomes

  1. Home PD diary

    Time frame: 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 outcomes

  1. PD Home diary

    Time frame: during six months of follow-up

    ON time without troublesome dyskinesia

  2. PD Home diary

    Time frame: during six months of follow-up

    ON time with troublesome dyskinesia

  3. PD Home diary

    Time frame: during six months of follow-up

    ON time without dyskinesia

  4. PD Home diary

    Time frame: during six months of follow-up

    OFF time

  5. PD Home diary

    Time frame: during six months of follow-up

    Asleep time

  6. MDS-UPDRS III (ON and OFF phase)

    Time frame: change from baseline to six months of DBS

    Motor symptoms

  7. MDS-UPDRS IV

    Time frame: change from baseline to six months of DBS

    Motor complication including motor fluctuations and dyskinesias

  8. Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)

    Time frame: change from baseline to six months of DBS

    Level of physical disability

  9. Parkinson's Disease Questionnaire 39 (PDQ-39)

    Time frame: change from baseline to six months of DBS

    Quality of life

  10. Dopaminergic medication usage

    Time frame: during six months of follow-up

  11. Montreal Cognitive Assessment (MoCA)

    Time frame: change from baseline to six months of DBS

    MoCA is a cognitive screening tool for detecting and scoring cognitive impairment

  12. Beck Depression Inventory (BDI)

    Time frame: change from baseline to six months of DBS

    Mood status

  13. Starkstein Apathy Scale (SAS)

    Time frame: change from baseline to six months of DBS

    Apathy status

  14. Parkinson's Disease Sleep Scale (PDSS-2)

    Time frame: during six months of follow-up

    Sleep disturbances and quality of sleep

  15. Side effects

    Time frame: during six months of follow-up

    Number and sort of side effects

  16. Time of DBS titration

    Time frame: during six months of follow-up

    Duration of DBS titration based on the number and duration of hospital visits

  17. Time to final adjustment of the DBS settings

    Time frame: during six months of follow-up

    first time point for stimulation parameters following the last adjustment of the stimulation parameters

  18. Assessor's evaluation of the ease of programming

    Time frame: after six months of follow-up

    Five-point Likert scale

  19. Beta oscillatory activity

    Time frame: during six months of follow-up

    Amount of decrease of oscillatory activity in the beta range

  20. DBS settings (1)

    Time frame: during six months of follow-up

    Electrical energy consumption expressed by the Total electrical energy delivered (TEED)

  21. DBS settings (2)

    Time frame: during six months of follow-up

    DBS amplitudes in mA

  22. DBS settings (3)

    Time frame: during six months of follow-up

    Average stimulation fraction expressed as percentages

  23. LFP characteristics (2)

    Time frame: during six months of follow-up

    Beta power spectral density expressed as µV²/Hz

  24. LFP characteristics (2)

    Time frame: during six months of follow-up

    Beta volatility expressed as a.u.

  25. Participant's evaluation of the burden of the treatment

    Time frame: after six months of follow-up

    Five-point Likert scale

  26. Participant's satisfaction on the outcome of treatment

    Time frame: after six months of follow-up

    Five-point Likert scale

Study contacts

Contact information is provided by the study sponsor or research team.

M. Beudel, MD, PhD

CONTACT

[email protected]

+31 20 566 9111

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • HagaZiekenhuis
  • Maastricht University Medical Center
  • Universitair Ziekenhuis Leuven

Registry information

Official study title

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

Acronym: CLOSE-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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