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Brain pacemaker may curb risky behaviors in Parkinson's patients

NCT ID NCT06498349

Disease control Sponsor: University of Kiel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares deep brain stimulation (DBS) plus medication against medication alone for Parkinson's patients who also have impulse control disorders, like gambling or compulsive behaviors. About 60 participants aged 70 or younger will be randomly assigned to one of the two groups. The goal is to see if adding DBS can better reduce these behavioral issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at the time of enrollment: ≤ 70 years 2. Diagnosis of PD according to MDS clinical diagnostic criteria 3. Onset of first PD motor symptoms ≥ 4 years 4. Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use 5. MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest 6. Adaptation of medical therapy has been attempted 7. MoCA ≥ 24 in the meds on condition 8. BDI-II score \< 20 in the meds on condition, or Patients with moderately severe depression with a BDI-II between 20 and 28 points, strict consideration must be made with the involvement of a psychiatrist. Patients must be willing and able to comply this. 9. Patients able to understand the study requirements and the treatment procedures 10. Written informed consent before any study-specific tests or procedures are performed Exclusion Criteria: 11. Surgical contraindications to undergo DBS operation 12. Ongoing severe depression (BDI-II \> 28) 13. suicidal ideation (item 9 of BDI-II \> 1) 14. Dementia (MoCA \< 24) in the meds on condition 15. Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation 16. Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system 17. Simultaneous participation in another clinical trial targeting or potentially interfering with ICD 18. Any history of recurrent seizures or haemorrhagic stroke 19. Fertile women not using adequate contraceptive methods 20. Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care 21. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception 22. Any impairment that would limit subject's ability to participate in the study and perform study procedures 23. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints

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Conditions

The condition(s) this trial relates to.

Disruptive, Impulse Control, and Conduct Disorders impulse control disorder Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Impulse control disorders Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, Netherlands

  • Charité Campus Mitte

    RECRUITING

    Mitte, Germany

  • University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, Germany

  • University Hospital Cologne

    RECRUITING

    Cologne, Germany

  • University Hospital Duesseldorf

    RECRUITING

    Düsseldorf, Germany

  • University Hospital Schleswig-Holstein (UKSH), Campus Kiel

    RECRUITING

    Kiel, Germany

  • University Hospital Tuebingen

    RECRUITING

    Tübingen, Germany

  • University Hospital Wuerzburg

    RECRUITING

    Würzburg, Germany

  • University Hospital Zuerich (USZ)

    RECRUITING

    Zurich, Switzerland

  • University Hospital of Bern (Inselspital)

    RECRUITING

    Bern, Switzerland

  • University Hospital of Giessen and Marburg (UKGM), Campus Marburg

    RECRUITING

    Marburg, Germany

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.