AzTrials
AzTrials

Parkinson DiseaseNCT06498349

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

A study testing bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment and 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 in people with Parkinson Disease and Impulse Control Disorders, run by University of Kiel at 13 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Parkinson Disease, Impulse Control Disorders
What is being tested?
bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment and 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
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
13 sitesin 3 countries
Study dates
5 Sep 2024to 15 Jul 2028
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at the time of enrollment: ≤ 70 years
  • Diagnosis of PD according to MDS clinical diagnostic criteria
  • Onset of first PD motor symptoms ≥ 4 years
  • 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
  • MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
  • Adaptation of medical therapy has been attempted
Show all 10Show fewer
  • MoCA ≥ 24 in the meds on condition
  • 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.
  • Patients able to understand the study requirements and the treatment procedures
  • Written informed consent before any study-specific tests or procedures are performed

Who cannot join

  • Surgical contraindications to undergo DBS operation
  • Ongoing severe depression (BDI-II > 28)
  • suicidal ideation (item 9 of BDI-II > 1)
  • Dementia (MoCA < 24) in the meds on condition
  • Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
  • Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
Show all 13Show fewer
  • Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
  • Any history of recurrent seizures or haemorrhagic stroke
  • Fertile women not using adequate contraceptive methods
  • Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
  • A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
  • Any impairment that would limit subject's ability to participate in the study and perform study procedures
  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints

Trial locations and contacts

13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Steffen Paschen, MD contact

+49 (0)431 500 ext. 23819

steffen.paschen@uksh.de

Guenther Deuschl, Prof. contact

g.deuschl@neurologie.uni-kiel.de

13 sites in 3 countries

Germany10 sites, 10 recruiting

  • University Hospital Cologne

    Cologne

    Michael Barbe, MD

    Veerle Visser-Vandewalle, Prof.

    Recruiting

  • University Hospital Carl Gustav Carus

    Dresden

    Bjoern Falkenburger, Prof.

    Bjoern Falkenburger, Prof.

    Recruiting

  • University Hospital Duesseldorf

    Düsseldorf

    Alfons Schnitzler, Prof.

    Jan Vesper, Prof.

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Monika Poetter-Nerger, MD

    Monika Poetter-Nerger, PD

    Recruiting

  • Paracelsus-Elena Klinik

    Kassel

    Clemens Jacksch, MD, +49 0561 6009 ext. -239, clemens.jacksch@pkd.de

    Clemens Jacksch, MD

    Not yet recruiting

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

    Kiel

    Steffen Paschen, MD

    Guenter Deuschl, Prof.

    Recruiting

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

    Marburg

    David Pedrosa, Prof.

    David Pedrosa, Prof.

    Recruiting

  • Charité Campus Mitte

    Mitte

    Patricia Krause, MD

    Andrea Kühn, Prof.

    Recruiting

  • University Hospital Tuebingen

    Tübingen

    Daniel Weiss, Prof.

    Daniel Weiss, Prof.

    Recruiting

  • University Hospital Wuerzburg

    Würzburg

    Philipp Carpetian, MD

    Jens Volkmann, Prof.

    Recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • University Hospital of Bern (Inselspital)

    Bern

    Ines Deboves, MD

    Paul Krack, Prof.

    Recruiting

  • University Hospital Zuerich (USZ)

    Zurich

    Lennart Stieglitz, Prof.

    Fabian Buechele, MD

    Recruiting

Other trials in Switzerland

Netherlands1 site, 1 recruiting

  • Amsterdam University Medical Center

    Amsterdam

    Rob MA De Bie, Prof.

    Annabel von der Weide, MD

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
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
Medical subject headings
Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatmentProcedure or surgery

    Also called best medical treatment for management of impulse control in Parkinson´s disease

    according to widely accepted expert consensus paper

  • best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group RecommendationsDrug

    according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.

Study groups in NCT06498349
Study groupRoleWhat they receive
DBS-groupOtherWithin indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment
Receives: Procedure: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment; Drug: 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
BMT-groupOtherWithin indication and clinical routine: best medical treatment
Receives: Drug: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups with respect to the hyperdopaminergic sub-score

    Measured: 12 months

Secondary outcomes (20)

  1. Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  2. Starkstein-Apathy-Scale (SAS)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  3. Hospital Anxiety and Depression Scale (HADS)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  4. Beck Depression Inventory (BDI)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  5. suicidal item 9 of the BDI

    safety focus on suicidal item 9 of the BDI with reference to the question for the last 2 months

    Measured: 12 months

  6. Neuropsychiatric-fluctuations scale (NFS)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  7. Young mania rating scale (YMRS)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  8. Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  9. Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  10. MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  11. Marconi Dyskinesia Rating Scale

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  12. Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  13. Pittsburgh Sleep Quality Index (PSQI)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  14. Safety weight monitoring (BMI control)

    Difference of change from baseline to follow-up between the two treatment groups

    Measured: 12 months

  15. Montreal Cognitive Assessment (MoCA)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  16. Clinical Global Impression (CGI-S, Severity) (CGI-C, Change)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  17. Patient Global Impression (PGI-S, Severity) (PGI-C, Change)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  18. Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment)

    Difference of change (improvement) from baseline to follow-up between the two treatment groups

    Measured: 12 months

  19. Adverse events

    Reporting and analysis of adverse events: Frequency, type and severity of therapy related relevant adverse events of medication or DBS

    Measured: 12 months

  20. Parkinson's disease Dysarthria Compound Score (PD-DCS)

    An intra-group comparison will be performed between the individual patient's safety speech outcome of Parkinson's disease Dysarthria Compound Score (PD-DCS) The PD-DCS is a speech acoustic summary measure of the main speech affected domains in PD, namely monopitch, monoloudness, imprecise consonants, inappropriate silences, harsh/breathy voice, and speech timing abnormalities. Acoustic proxy measures of these perceptual speech domains can be extracted from speech using modern acoustic speech analysis.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2024
  2. Study start5 Sep 2024
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2028 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Better personalized therapy adaptation and care for patients with behavioral disorders is possible. This is often currently not possible in routine clinical practice. The scale for primary outcome used as the main target has been tested for use and is suitable for the study purpose of monitoring ICD. We now want to examine what patients with ICD benefit most from.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498349
Sponsor's protocol ID
KKS-313
Status last verified
Oct 2026
First submitted
17 Jun 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment and 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 in people with Parkinson Disease and Impulse Control Disorders, run by University of Kiel at 13 sites in 3 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 10 inclusion and 13 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Switzerland, Netherlands. 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 Steffen Paschen, MD (+49 (0)431 500 ext. 23819, steffen.paschen@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06498349.

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 20 Oct 2026.

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