Deep Brain StimulationCLOSE-PDNCT06909045
Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
A study testing Adaptive DBS and Continue DBS in people with Deep Brain Stimulation and Parkinson Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- Adaptive DBS and Continue DBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 27 Jan 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Martijn Beudel, MD, PhD
- Not yet recruiting
Maastricht UMC+
Maastricht
M.L.F. Janssen, MD, PhD
- Not yet recruiting
HagaZiekenhuis
The Hague
M.F. Contarino, MD, PhD
Belgium1 site, 1 recruiting
- Not yet recruiting
UZ Leuven
Leuven
B. Swinnen, MD, PhD
About this study
Official title: Randomized Controlled Trial Comparing Adaptive Versus 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?
Read more
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.
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Being tested
- Adaptive DBS, Continue DBS
- Keywords
- adaptive DBS, continue DBS, aDBS, cDBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive DBSOther
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
Continue DBSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| aDBS group | Experimental | 65 patients with Parkinson's disease will receive adaptive DBS. Receives: Other: Adaptive DBS |
| cDBS group | Active comparator | 65 patients with Parkinson's disease will receive continue DBS. Receives: Other: Continue DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home PD diary
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
Measured: change from baseline to six months of DBS
Secondary outcomes (26)
PD Home diary
ON time without troublesome dyskinesia
Measured: during six months of follow-up
PD Home diary
ON time with troublesome dyskinesia
Measured: during six months of follow-up
PD Home diary
ON time without dyskinesia
Measured: during six months of follow-up
PD Home diary
OFF time
Measured: during six months of follow-up
PD Home diary
Asleep time
Measured: during six months of follow-up
MDS-UPDRS III (ON and OFF phase)
Motor symptoms
Measured: change from baseline to six months of DBS
MDS-UPDRS IV
Motor complication including motor fluctuations and dyskinesias
Measured: change from baseline to six months of DBS
Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)
Level of physical disability
Measured: change from baseline to six months of DBS
Parkinson's Disease Questionnaire 39 (PDQ-39)
Quality of life
Measured: change from baseline to six months of DBS
Dopaminergic medication usage
Measured: during six months of follow-up
Montreal Cognitive Assessment (MoCA)
MoCA is a cognitive screening tool for detecting and scoring cognitive impairment
Measured: change from baseline to six months of DBS
Beck Depression Inventory (BDI)
Mood status
Measured: change from baseline to six months of DBS
Starkstein Apathy Scale (SAS)
Apathy status
Measured: change from baseline to six months of DBS
Parkinson's Disease Sleep Scale (PDSS-2)
Sleep disturbances and quality of sleep
Measured: during six months of follow-up
Side effects
Number and sort of side effects
Measured: during six months of follow-up
Time of DBS titration
Duration of DBS titration based on the number and duration of hospital visits
Measured: during six months of follow-up
Time to final adjustment of the DBS settings
first time point for stimulation parameters following the last adjustment of the stimulation parameters
Measured: during six months of follow-up
Assessor's evaluation of the ease of programming
Five-point Likert scale
Measured: after six months of follow-up
Beta oscillatory activity
Amount of decrease of oscillatory activity in the beta range
Measured: during six months of follow-up
DBS settings (1)
Electrical energy consumption expressed by the Total electrical energy delivered (TEED)
Measured: during six months of follow-up
DBS settings (2)
DBS amplitudes in mA
Measured: during six months of follow-up
DBS settings (3)
Average stimulation fraction expressed as percentages
Measured: during six months of follow-up
LFP characteristics (2)
Beta power spectral density expressed as µV²/Hz
Measured: during six months of follow-up
LFP characteristics (2)
Beta volatility expressed as a.u.
Measured: during six months of follow-up
Participant's evaluation of the burden of the treatment
Five-point Likert scale
Measured: after six months of follow-up
Participant's satisfaction on the outcome of treatment
Five-point Likert scale
Measured: after six months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start27 Jan 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- HagaZiekenhuis, Maastricht University Medical Center, Universitair Ziekenhuis Leuven
- Responsible party
- Principal investigator, dr. Martijn Beudel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Martijn Beudel, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909045
- Sponsor's protocol ID
- NL009220
- Acronym
- CLOSE-PD
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, IPD will be shared through restricted access via a secure online database.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06909045
- Acronym / sponsor ID
- CLOSE-PD / NL009220
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Keywords
- adaptive DBS, continue DBS, aDBS, cDBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- HagaZiekenhuis, Maastricht University Medical Center, Universitair Ziekenhuis Leuven
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aDBS group | Experimental | Other: Adaptive DBS65 patients with Parkinson's disease will receive adaptive DBS. |
| cDBS group | Active comparator | Other: Continue DBS65 patients with Parkinson's disease will receive continue DBS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive DBSThe Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS. | Other | aDBS group |
| Continue DBSThe 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. | Other | cDBS group |
Primary outcome
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
26 secondary outcomes
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
Starkstein Apathy Scale (SAS)
Time frame: change from baseline to six months of DBS
Parkinson's Disease Sleep Scale (PDSS-2)
Time frame: during six months of follow-up
Side effects
Time frame: during six months of follow-up
Time of DBS titration
Time frame: during six months of follow-up
Time to final adjustment of the DBS settings
Time frame: during six months of follow-up
Assessor's evaluation of the ease of programming
Time frame: after six months of follow-up
Beta oscillatory activity
Time frame: during six months of follow-up
DBS settings (1)
Time frame: during six months of follow-up
DBS settings (2)
Time frame: during six months of follow-up
DBS settings (3)
Time frame: during six months of follow-up
LFP characteristics (2)
Time frame: during six months of follow-up
LFP characteristics (2)
Time frame: during six months of follow-up
Participant's evaluation of the burden of the treatment
Time frame: after six months of follow-up
Participant's satisfaction on the outcome of treatment
Time frame: after six months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Upon request, IPD will be shared through restricted access via a secure online database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martijn Beudel, MD, PhD principal investigator
Amsterdam UMC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive DBS and Continue DBS in people with Deep Brain Stimulation and Parkinson Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M. Beudel, MD, PhD (+31 20 566 9111, closepd@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home PD diary (time frame: change from baseline to six months of DBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.