Parkinson DiseasePREVENT-ICDNCT07505394
Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease
A study testing Algorithm-guided group in people with Parkinson Disease and Impulse Control Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Impulse Control Disorder
- What is being tested?
- Algorithm-guided group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2026to 15 Oct 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Pitié Salpêtrière, APHP service de neurologie
Paris, 75013
About this study
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)
Read the detailed description
This Clinical Investigation is a multicenter comparative randomized, controlled, masked (patient and primary criteria evaluator), superiority trial, with 2 parallel groups (Intervention group: Algorithm-guided arm; Control group: standard of care arm).
PD patients, treated by DA at inclusion, will be randomized (1:1 ratio) either to the standard of care (SoC) arm, or to the Algorithm-guided arm. They will be recruited at PD expert centers of the NSPARK/FCRIN network. The primary objective is to assess the efficacy of the ICD SHIELD app, a software with a computer-based algorithm assisting clinicians in the prescription of dopaminergic medications, as compared to the standard of care, on the primary endpoint After the inclusion (V0 at M0), four follow-up visits will be performed : V1 at M9, V2 at M18, V3 at M27 and V4 at M36 during outpatients clinics where participants are usually followed. At each follow up visit (M9 to M36), the neurologist will record medical and treatment history, perform neurological examination MDS-UPDRS sections III to IV and CGI-I scale, and will review the MDS-UPDRS sections I and II for potential reassessment/clarification. The PGI scale, PDQ39 questionnaire, MDS-UPDRS sections I and II, and the HAD scales will be filled by the patient. The MoCA scale, ASBPD and QUIP-RS will be performed by a neuropsychologist, or an investigator trained for each scale, according to scoring instructions and blind to treatment arm allocation. Then, the treatment will be adapted by the neurologist, according to the recommendation by the algorithm output or to the clinician sole recommendation depending on the arm in which the patient is randomized.
An additional phone call will be made 3 months after the previous visit for a remote checkup to confirm that the prescription change (decreasing or stopping DA) has been properly followed by the patient, if the adjustment to stop completely or decrease DA to a dose equivalent of 40mg of Levodopa was applied.
An optional blood sample will be drawn at baseline or at a follow-up visit and sent for DNA extraction and biobanking at the ICM, Pitié-Salpêtrière Hospital, Paris. The duration of recruitment will be 2 years. The duration of participation for each participant will be 3 years, the total duration of the study will be 5 years.
The main analysis will be in Intention to treat and will involve a mixed generalized linear model (GLMM) with a logit link adjusted for minimization stratification factors (center, sex, age, Levodopa Equivalent Daily Dose (LEDD) at inclusion).
- Conditions
- Parkinson Disease, Impulse Control Disorder
- Being tested
- Algorithm-guided group, Standard of Care (SoC) group
- Keywords
- Agonists, Dopamine, Impulse Control Disorders, ICD SHIELD app
- 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.
Algorithm-guided groupDevice
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) groupBehavioural
In the SoC arm the patient treatment will be adapted by the neurologistbased only on their clinical appreciation and international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm-guided group | Experimental | In the (algorithm-guided arm) the patient treatment will be adapted by the neurologist based on the algorithm output. Receives: 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. Receives: Behavioral: Standard of Care (SoC) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 3 years
Secondary outcomes (23)
Perception of global disease severity by the patient
Change in disease severity of PD on the Patient Global Impression of Improvement (PGI-I) scale filled by the patient over the 3 year-long-follow up.
The PGI is a Patient Global Impression 7-point scale that requires the rating of the severity of the patient's illness at the time of assessment. It is assessed by asking the patient at each visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation. A higher value indicates increased improvement from Clinical Investigation start, ranging from 1=very much worse to 7=very much improved.
Measured: over 3 years
Perception of global disease severity by the clinician
Change in disease severity of PD on the Clinical Global Impression of Improvement (CGI-I) scale filled by the clinician over the 3 year-long-follow up.
The Change in the Neurologist (clinician) Global Impression of Improvement (CGI-I) provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The Clinical Global Impression-Improvement scale rates total improvement on a 7-point scale: 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse.
Measured: over 3 years
Time to onset of first occurrence of clinically significant ICDRBs
Time to onset of a first clinically significant ICDRBs, i.e mild or above, defined as 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-long-follow up.
Measured: over 3 years
Global severity of ICDRBs at time of first occurrence on the QUIP-RS score
Severity of ICDRBs at time of first occurrence assessed on the Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS) score (Score ranges from 0 to 112, a higher score reflecting a more severe ICDRB) over the 3 year-long-follow up.
Measured: over 3 years
Highest severity of ICDRBs at time of first occurrence on the ASBPD score
Severity of ICDRBs at time of first occurrence assessed on ASBPD score (highest severity on part IV of the ASBPD, hyperdopaminergic behaviors, in any of the subcategories 3 to 5 and 7 to 10) over the 3 year-long-follow up.
Measured: over 3 years
Global severity of ICDRBs at time of first occurrence on the ASBPD score
Global severity of ICDRBs at time of first occurrence assessed by the sum of ICDRBs items' scores on ASBPD (subcategories 3 to 5 and 7 to 10 of the part IV hyperdopaminergic behaviors) over the 3 year-long-follow up.
Measured: over 3 years
Cumulative levodopa equivalent daily dose (LEDD)
Intakes of dopaminergic medications will be calculated to an equivalent dose of levodopa allowing for standardized evaluation of medication intake among PD patients by expressing dose intensity of different antiparkinsonian drug regimens on a single scale ((Jost et al., 2023; Tomlinson et al., 2010). Cumulative LEDD will be assessed as the sum of the daily doses over the 3 year-follow up, recorded at each visit (M9 M18, M27, M36).
Measured: over 3 years
Time to first DA stopping
Time to onset of a first DA stopping, whatever the reason, over the 3 year-long-follow up.
Measured: over 3 years
Reasons for first DA stopping
Rate of each reasons given by the neurologist for the first DA stopping over the 3 year-long-follow up, among: clinically significant ICDRBs, other adverse event of DA than ICDRBs, risk of clinically significant ICDRBs as judged by the neurologist and/or the ICD SHIELD app, insufficient efficacy, other or unknown reason.
Measured: over 3 years
Motor control
Change in motor score on the MDS-UPDRS (MDS-UPDRS III sub-score) over the 3 year-long-follow up.
Score between 0 and 132, a higher score reflects a more severe motor state. The MDS-UPDRS III sub-score is the gold standard for measuring the clinical motor state of PD patients.
Measured: over 3 years
Dyskinesia
Change in the dyskinesia score on the MDS-UPDRS (sum of MDS-UPDRS IV items 4.1 and 4.2) over the 3 years.
Measured: over 3 years
Motor fluctuation
Change in the motor fluctuations score on the MDS-UPDRS (sum of MDS-UPDRS IV items 4.3 to 4.6) over the 3 years.
Measured: over the 3 years.
Depression (MDS-UPDRS scale)
Change in depression score item 1.3 of the MDS-UPDRS scale over the 3 year-follow up
Measured: over 3 years
Depression (HADS subscore)
Change in HADS depression subscore over the 3 year-follow up. It comprises 14 items each ranging from 0 to 3. Seven questions are evaluating anxiety (total A) and seven others to depressive dimension (total D), obtaining two scores (maximal score = 21 for each). A higher value indicates increased anxiety (total A) or depression (total D).
Measured: over 3 years
Anxiety (MDS-UPDRS scale)
Change in anxiety score item 1.4 of the MDS-UPDRS scale over the 3 year-follow up
Measured: over 3 years
Anxiety (HADS subscore)
Change in HADS anxiety subscore over the 3 year-follow up. It comprises 14 items each ranging from 0 to 3. Seven questions are evaluating anxiety (total A) and seven others to depressive dimension (total D), obtaining two scores (maximal score = 21 for each). A higher value indicates increased anxiety (total A) or depression (total D).
Measured: over 3 years
Somnolence
Change in somnolence score item 1.8 of the MDS-UPDRS over the 3 year-follow up
Measured: over 3 years
Sleep disorders
Change in sleep issues score item 1.7 of the MDS-UPDRS over the 3 year-follow up
Measured: over 3 years
Apathy
Change in apathy score item 1.5 of the MDS-UPDRS scale over the 3 year-follow up
Measured: over 3 years
Cognition
Change in cognition MoCA scale over the 3 year-follow up. The MoCA is a 30-point cognitive screening instrument that assesses visuospatial, executive, naming, attention, language, abstraction, delayed recall, and orientation domains. A cutoff score of 26 is normative cognitive function.
Measured: over 3 years
Serious Adverse Events
Number, type and imputability of serious adverse events within a 3 year follow up period.
Measured: over 3 years
Observance of the ICD SHIELD app for clinicians
Percentage of visits in which the clinician decided not to follow ICD SHIELD app recommendation over the 3 year-follow up
Measured: over 3 years
Acceptability of the ICD SHIELD app for clinicians
Reasons for not following the ICD SHIELD app recommendation: a short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively
Measured: over 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start13 Oct 2026
- Primary completion15 Oct 2031 (estimated)
- Study completion15 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NS-PARK Network
- Responsible party
- Sponsor
- Investigators
- Louise-Laure Mariani, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505394
- Sponsor's protocol ID
- APHP220831
- Other IDs
- 2024-A02552-45
- Acronym
- PREVENT-ICD
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request to the Coordinating Principal Investigator/Corresponding author, and according to local regulations and depending on futur use of the medical device in case of CE mark and commercialization. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07505394
- Acronym / sponsor ID
- PREVENT-ICD / APHP220831
- Conditions
- Parkinson Disease, Impulse Control Disorder
- Keywords
- Agonists, Dopamine, Impulse Control Disorders, ICD SHIELD app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NS-PARK Network
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 15 Oct 2031 (estimated)
- Study completion
- 15 Oct 2031 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This Clinical Investigation is a multicenter comparative randomized, controlled, masked (patient and primary criteria evaluator), superiority trial, with 2 parallel groups (Intervention group: Algorithm-guided arm; Control group: standard of care arm).
PD patients, treated by DA at inclusion, will be randomized (1:1 ratio) either to the standard of care (SoC) arm, or to the Algorithm-guided arm. They will be recruited at PD expert centers of the NSPARK/FCRIN network. The primary objective is to assess the efficacy of the ICD SHIELD app, a software with a computer-based algorithm assisting clinicians in the prescription of dopaminergic medications, as compared to the standard of care, on the primary endpoint After the inclusion (V0 at M0), four follow-up visits will be performed : V1 at M9, V2 at M18, V3 at M27 and V4 at M36 during outpatients clinics where participants are usually followed. At each follow up visit (M9 to M36), the neurologist will record medical and treatment history, perform neurological examination MDS-UPDRS sections III to IV and CGI-I scale, and will review the MDS-UPDRS sections I and II for potential reassessment/clarification. The PGI scale, PDQ39 questionnaire, MDS-UPDRS sections I and II, and the HAD scales will be filled by the patient. The MoCA scale, ASBPD and QUIP-RS will be performed by a neuropsychologist, or an investigator trained for each scale, according to scoring instructions and blind to treatment arm allocation. Then, the treatment will be adapted by the neurologist, according to the recommendation by the algorithm output or to the clinician sole recommendation depending on the arm in which the patient is randomized.
An additional phone call will be made 3 months after the previous visit for a remote checkup to confirm that the prescription change (decreasing or stopping DA) has been properly followed by the patient, if the adjustment to stop completely or decrease DA to a dose equivalent of 40mg of Levodopa was applied.
An optional blood sample will be drawn at baseline or at a follow-up visit and sent for DNA extraction and biobanking at the ICM, Pitié-Salpêtrière Hospital, Paris. The duration of recruitment will be 2 years. The duration of participation for each participant will be 3 years, the total duration of the study will be 5 years.
The main analysis will be in Intention to treat and will involve a mixed generalized linear model (GLMM) with a logit link adjusted for minimization stratification factors (center, sex, age, Levodopa Equivalent Daily Dose (LEDD) at inclusion).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm-guided group | Experimental | Device: Algorithm-guided groupIn the (algorithm-guided arm) the patient treatment will be adapted by the neurologist based on the algorithm output. |
| Standard of Care (SoC) group | Other | Behavioral: Standard of Care (SoC) groupIn the SoC arm the patient treatment will be adapted by the neurologist based only on their clinical appreciation and international guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Atypical or secondary parkinsonism such as supranuclear palsy, multisystem atrophy or drug-induced parkinsonism, etc...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm-guided groupAfter 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. | Device | Algorithm-guided group |
| Standard of Care (SoC) groupIn the SoC arm the patient treatment will be adapted by the neurologistbased only on their clinical appreciation and international guidelines. | Behavioural | Standard of Care (SoC) group |
Primary outcome
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.
Time frame: over 3 years
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
23 secondary outcomes
Perception of global disease severity by the patient
Time frame: over 3 years
Perception of global disease severity by the clinician
Time frame: over 3 years
Time to onset of first occurrence of clinically significant ICDRBs
Time frame: over 3 years
Global severity of ICDRBs at time of first occurrence on the QUIP-RS score
Time frame: over 3 years
Highest severity of ICDRBs at time of first occurrence on the ASBPD score
Time frame: over 3 years
Global severity of ICDRBs at time of first occurrence on the ASBPD score
Time frame: over 3 years
Cumulative levodopa equivalent daily dose (LEDD)
Time frame: over 3 years
Time to first DA stopping
Time frame: over 3 years
Reasons for first DA stopping
Time frame: over 3 years
Motor control
Time frame: over 3 years
Dyskinesia
Time frame: over 3 years
Motor fluctuation
Time frame: over the 3 years.
Depression (MDS-UPDRS scale)
Time frame: over 3 years
Depression (HADS subscore)
Time frame: over 3 years
Anxiety (MDS-UPDRS scale)
Time frame: over 3 years
Anxiety (HADS subscore)
Time frame: over 3 years
Somnolence
Time frame: over 3 years
Sleep disorders
Time frame: over 3 years
Apathy
Time frame: over 3 years
Cognition
Time frame: over 3 years
Serious Adverse Events
Time frame: over 3 years
Observance of the ICD SHIELD app for clinicians
Time frame: over 3 years
Acceptability of the ICD SHIELD app for clinicians
Time frame: over 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request to the Coordinating Principal Investigator/Corresponding author, and according to local regulations and depending on futur use of the medical device in case of CE mark and commercialization. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise-Laure Mariani study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm-guided group in people with Parkinson Disease and Impulse Control Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 6 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 16 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 1 site in France. 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 Louise-Laure Mariani, Doctor ((+33) 1 42 16 27 48, louise-laure.mariani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: over 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.