---
title: Reduce impulse control disorder behaviors
nct_id: NCT06498349
phase: NA
status: RECRUITING
sponsor: University of Kiel
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06498349"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06498349"
last_fetched: "2026-05-10T14:08:06.816Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce impulse control disorder behaviors

**Goal (in five words):** Reduce impulse control disorder behaviors

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

**Trial ID:** [NCT06498349](https://clinicaltrials.gov/study/NCT06498349)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University of Kiel
- **Target Enrollment:** 60 participants
- **Start Date:** 2024-09-05
- **Completion Date:** 2027-07-15
- **Conditions:** Parkinson Disease, Impulse Control Disorders
- **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
- **Intervention Types:** PROCEDURE, DRUG

## Summary For Families

The goal is to reduce impulse control problems like pathological gambling, hypersexuality, compulsive shopping or eating in people with Parkinson's, while also treating levodopa‑responsive motor symptoms. The approach implants bilateral, high‑frequency deep brain stimulation electrodes into the subthalamic nucleus to deliver continuous electrical pulses that calm abnormal circuit activity; that often improves motor signs and can allow lowering dopaminergic medications that may drive impulse behaviors, and it is combined with individualized best medical treatment and medication adjustment. They are enrolling adults 18 to 70 with Parkinson's for at least 4 years who show good levodopa response or classic rest tremor, who have moderate to severe impulse control disorders despite trying medication changes, who have preserved cognition (MoCA ≥24) and no severe depression or surgical contraindications.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (12)

- University Hospital Cologne, Cologne, Germany _(50.9333, 6.9500)_
  - Michael Barbe, MD — (CONTACT)
  - Veerle Visser-Vandewalle, Prof. — (CONTACT)
- University Hospital Carl Gustav Carus, Dresden, Germany _(51.0509, 13.7383)_
  - Bjoern Falkenburger, Prof. — (CONTACT)
- University Hospital Duesseldorf, Düsseldorf, Germany _(51.2232, 6.7793)_
  - Alfons Schnitzler, Prof. — (CONTACT)
  - Jan Vesper, Prof. — (CONTACT)
- University Medical Center Hamburg-Eppendorf, Hamburg, Germany _(53.5507, 9.9930)_
  - Monika Poetter-Nerger, MD — (CONTACT)
- University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany _(54.3213, 10.1349)_
  - Steffen Paschen, MD — (CONTACT)
  - Guenter Deuschl, Prof. — (CONTACT)
- University Hospital of Giessen and Marburg (UKGM), Campus Marburg, Marburg, Germany _(50.8090, 8.7707)_
  - David Pedrosa, MD — (CONTACT)
- Charité Campus Mitte, Mitte, Germany _(52.5200, 13.4049)_
  - Patricia Krause, MD — (CONTACT)
  - Andrea Kühn, Prof. — (CONTACT)
- University Hospital Tuebingen, Tübingen, Germany _(48.5227, 9.0522)_
  - Daniel Weiss, Prof. — (CONTACT)
- University Hospital Wuerzburg, Würzburg, Germany _(49.7939, 9.9512)_
  - Philipp Carpetian, MD — (CONTACT)
  - Jens Volkmann, Prof. — (CONTACT)
- Amsterdam University Medical Center, Amsterdam, Netherlands _(52.3740, 4.8897)_
  - Rob MA De Bie, Prof. — (CONTACT)
  - Annabel von der Weide, MD — (CONTACT)
- University Hospital of Bern (Inselspital), Bern, Switzerland _(46.9481, 7.4474)_
  - Ines Deboves, MD — (CONTACT)
  - Paul Krack, Prof. — (CONTACT)
- University Hospital Zuerich (USZ), Zurich, Switzerland _(47.3667, 8.5500)_
  - Lennart Stieglitz, Prof. — (CONTACT)
  - Fabian Buechele, MD — (CONTACT)
  - Sujitha Mahendran, MD — (SUB_INVESTIGATOR)

## Central Contacts

- Steffen Paschen, MD — (CONTACT) — +49 (0)431 500 — steffen.paschen@uksh.de
- Guenther Deuschl, Prof. — (CONTACT) — g.deuschl@neurologie.uni-kiel.de

---

*Canonical: https://parkinsonspathways.com/trial/NCT06498349*  
*HTML version: https://parkinsonspathways.com/trial/NCT06498349*  
*Source data: https://clinicaltrials.gov/study/NCT06498349*