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

NCT07505394 | Not Yet Recruiting

• 2 other identifiers: APHP2208312024-A02552-45
• Study Type: interventional
• Target: 528
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Parkinson Disease; Impulse Control Disorder

Keywords

Agonists, Dopamine; Impulse Control Disorders; ICD SHIELD app

Outcome Measures

Primary Outcomes (1)

• Rate of patients with at least one clinically significant ICDRBs, i.e mild or above (any ASBPD score at 2 or above in any of the subcategories 3 to 5 and 7 to 10 of part IV) over the 3 year-follow up.

  ICDRBs will be screened for, every 6 months, with the internationally validated Ardouin Scale of Behavior in PD (ASBPD), according to scoring instructions, by a neuropsychologist or the neurologist trained for the scale. The diagnosis of a clinically significant ICDRB (MILD or above) relies on part IV of the ASBPD, hyperdopaminergic behaviors, for patients who score at 2 or above in any of the subcategories 3 to 5 and 7 to 10

  over 3 years

Secondary Outcomes (23)

• Perception of global disease severity by the patient

  over 3 years

• Perception of global disease severity by the clinician

  over 3 years

• Time to onset of first occurrence of clinically significant ICDRBs

  over 3 years

• Global severity of ICDRBs at time of first occurrence on the QUIP-RS score

  over 3 years

• Highest severity of ICDRBs at time of first occurrence on the ASBPD score

  over 3 years

Other Outcomes (15)

• Cumulative severity of ICDRBs

  over 3 years

• Subtypes of ICDRBs

  over 3 years

• Patient quality of life

  over 3 years

Study Arms (2)

Algorithm-guided group

EXPERIMENTAL

In the (algorithm-guided arm) the patient treatment will be adapted by the neurologist based on the algorithm output.

Device: Algorithm-guided group

Standard of Care (SoC) group

OTHER

In the SoC arm the patient treatment will be adapted by the neurologist based only on their clinical appreciation and international guidelines.

Behavioral: Standard of Care (SoC) group

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.

Algorithm-guided group

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.

Standard of Care (SoC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• NS-PARK Network: collaborator

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Standard of Care; Population Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Demography; Population Characteristics

Study Officials

• Louise-Laure Mariani

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Louise-Laure Mariani, Doctor

CONTACT

01 42 16 27 48; louise-laure.mariani@aphp.fr

Sofia Zemouri, Master

CONTACT

01 42 16 75 75; sofia.zemouri@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodological sound proposal, with clearly identified processing purposes and subject to compliance with applicable regulations (CNIL, GDPR)