Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2028-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease Impulse Control Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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DBS-group

Within indication and clinical routine:

bilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment

Group Type OTHER

bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment

Intervention Type PROCEDURE

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 Recommendations

Intervention Type DRUG

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

BMT-group

Within indication and clinical routine:

best medical treatment

Group Type OTHER

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 Type DRUG

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

Interventions

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bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment

according to widely accepted expert consensus paper

Intervention Type PROCEDURE

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

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No