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Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease

Sponsor: Assistance Publique - Hôpitaux de Paris • ClinicalTrials.gov ID: NCT07505394

Registry updated: 2026-10-16

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Description

Impulse control disorders and related behaviors (ICDRBs) are characterized by pathological gambling, compulsive shopping or eating, and hypersexuality, but other related behaviors have been described, e.g. hobbyism, and punding. ICDRBs are frequent in Parkinson's Disease (PD), affecting up to 50% of the patients after 5 years with major medical, social, and legal impact, with life changing consequences for patients and caregivers. The main risk factor is dopaminergic therapy, particularly the cumulative dose of dopamine agonists (DA). On the other hand, the dopaminergic therapy is necessary to control motor symptoms, and DA have demonstrated efficacy in delaying motor complications occurring in PD. Ideally, dopaminergic therapy would have to be adjusted to the individual risk of developing ICRDBs to maximize the benefit/risk ratio of each drug. However, despite several clinical risk factors associated with the risk of ICDRBs (in addition to the dopaminergic therapy), it is still not possible to predict their risk at the individual level, and not every patient treated with dopaminergic medications will develop ICDRBs. A machine learning algorithm to predict ICDRBs, based on clinical data, validated by cross-validation on independent replication cohorts has been developed. The PREVENT-ICD study proposes to test the efficacy of a new application, ICD-Shield, based on an algorithm to predict and prevent ICDs,in a multicenter randomized controlled trial to prevent ICDRBs in PD patients by proposing to the clinician treatment adjustment according to the risk predicted by the algorithm, as compared to the standard of care (SoC)

Interventions

Algorithm-guided group (Device)
After the evaluation of the patient and the clinical inputs entered in the ICD SHIELD app including the planned choice of prescription by the neurologist for the next period, the clinician will receive the therapeutic approach recommended by the ICD SHIELD app depending on the output given by the algorithm. The clinician can repeat the use of the app if he/she plans to try various choice of prescription in the app if deemed necessary, but a single use is recommended at each visit. The neurologist will have to follow the recommendation of the ICD SHIELD app as much as possible unless judged inappropriate. The neurologist makes the final decision.
Standard of Care (SoC) group (Behavioral)
In the SoC arm the patient treatment will be adapted by the neurologistbased only on their clinical appreciation and international guidelines.

Eligibility criteria

Inclusion Criteria: * Male and female ≥ 18 years old * Diagnosis of PD according to the 2015 Movement Disorders Society criteria (Postuma et al., Mov Disord. 2015), with bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor; with no other suspected cause of parkinsonism * Disease duration below 6 years included * No ongoing clinically significant (Mild or above) ICDRBs (any ASBPD part IV subscores in any of the items 3 to 5 and 7 to 10 each \<2) * Patients currently treated with DA for at least 2 months and without current planned or known reason for stopping DA over the next 3 years Exclusion Criteria: * Atypical or secondary parkinsonism such as supranuclear palsy, multisystem atrophy or drug-induced parkinsonism, etc... * Patients with a cognitive or psychiatric disorder preventing patient's participation as per investigator's judgement * Not willing to participate to the Clinical Investigation or to sign the consent * Pregnant or lactating woman, or WOCBP tested positive in \<serum or urine\> pregnancy test * Participation in investigational drug trials within 30 days prior to screening or within 5 half-life of investigational product whatever the longest * Participant not affiliated or beneficiary of a French social security system

Conditions

Parkinson Disease Impulse Control Disorder

Locations

CHU Pitié Salpêtrière, APHP service de neurologie — Paris, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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