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Studying brain stimulation in people with impulse-control problems

Researchers examine implanted brain stimulation in people with Parkinson’s who also experience difficult-to-control behaviours.

Testing a treatment or activity · Study reference: NCT06498349

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2024-09-05
Main measurements finished (planned)
2027-07-15
Study finished (planned)
2028-07-15

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 18 years to 70 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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
Full study name & original research details

Official study title

A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders

Short title used by the registry

Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl

Original description

The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.

Conditions reported: Parkinson Disease; Impulse Control Disorders

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment; best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
Phases
NA
Sponsor
University of Kiel
Start date reported by registry
2024-09-05 (actual)

Registry updated: 2026-01-05 · Status last verified by the registry submitter: 2025-12

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Steffen Paschen, MD · +49 (0)431 500 · steffen.paschen@uksh.de

Guenther Deuschl, Prof. · g.deuschl@neurologie.uni-kiel.de

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University Hospital Cologne

Cologne, Germany

Recruiting

Michael Barbe, MD

Veerle Visser-Vandewalle, Prof.

University Hospital Carl Gustav Carus

Dresden, Germany

Recruiting

Bjoern Falkenburger, Prof.

University Hospital Duesseldorf

Düsseldorf, Germany

Recruiting

Alfons Schnitzler, Prof.

Jan Vesper, Prof.

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Recruiting

Monika Poetter-Nerger, MD

University Hospital Schleswig-Holstein (UKSH), Campus Kiel

Kiel, Germany

Recruiting

Steffen Paschen, MD

Guenter Deuschl, Prof.

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

Marburg, Germany

Recruiting

David Pedrosa, MD

Charité Campus Mitte

Mitte, Germany

Recruiting

Patricia Krause, MD

Andrea Kühn, Prof.

University Hospital Tuebingen

Tübingen, Germany

Recruiting

Daniel Weiss, Prof.

University Hospital Wuerzburg

Würzburg, Germany

Recruiting

Philipp Carpetian, MD

Jens Volkmann, Prof.

Amsterdam University Medical Center

Amsterdam, Netherlands

Recruiting

Rob MA De Bie, Prof.

Annabel von der Weide, MD

University Hospital of Bern (Inselspital)

Bern, Switzerland

Recruiting

Ines Deboves, MD

Paul Krack, Prof.

University Hospital Zuerich (USZ)

Zurich, Switzerland

Recruiting

Lennart Stieglitz, Prof.

Fabian Buechele, MD

Sujitha Mahendran, MD

Facility not reported

Germany

Status not reported

Facility not reported

Netherlands

Status not reported

Facility not reported

Switzerland

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.