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Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03141944
Acronym
IMPACT
Enrollment
90
Registered
2017-05-05
Start date
2017-02-23
Completion date
2020-03-11
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apathy, Parkinson Disease

Keywords

non motor symptoms

Brief summary

The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

Detailed description

All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study (Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667) between june 2012 and june 2016. 3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again. The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome. Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

Interventions

OTHERStarkstein scale of Apathy

The degree of apathy will be evaluated with the Starkstein scale of Apathy

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
33 Years to 72 Years
Healthy volunteers
No

Inclusion criteria

* patients who participated in Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667 * Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months * Patients with medical insurance * signed informed consent

Exclusion criteria

* diagnosis other than Parkinson's Disease * dementia (Mattis \<130) * patients protected by law (i.e. pregnant or parturient women)

Design outcomes

Primary

MeasureTime frameDescription
Evolution of apathy in Parkinson's disease1dayEvolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the Starkstein Scale of Apathy.

Secondary

MeasureTime frameDescription
Apparition of hyperdopaminergic symptoms in Parkinson's disease1 dayApparition of hyperdopaminergic symptoms in patients with Parkinson's disease under dopaminergic treatment, with the questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP) and the ECMP scale.
Evolution of impulsivity in Parkinson's disease1 dayEvolution of impulsivity in patients with Parkinson's disease under dopaminergic treatment. Evaluation with a self-assessment-questionnaire (UPPS Impulsive Behavior Scale)
Evolution of personality in Parkinson's disease1 dayEvolution of personality in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire Temperament and Character Inventory (TCI).
Evolution of hypodopaminergia in Parkinson's disease1 dayEvolution of hypodopaminergic symptoms in Patients with Parkinson's disease under dopaminergic treatment. Hypodopaminergic symptoms are evaluated with different scales: ECMP (behavioral evaluation in Parkinsons's disease) for depression and anxiety, STAI (State-trait-anxiety inventory, self-assessment-questionnaire for anxiety, BDI (Beck depression inventory) for depression, PFS-16 (Piper Fatigue Sale) for fatigue. Hypodopaminergia is the expressed as the sum of its symptoms.
Evolution of quality of life in Parkinson's disease1 dayEvolution of quality of life in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire PDQ39 (Parkinson's disease questionnaire).
Evolution of somnolence in Parkinson's disease1 dayEvolution of somnolence in patients with Parkinson's disease under dopaminergic treatment with the ECMP scale.
Evolution of eating behavior in Parkinson's disease1 dayEvolution of eating behavior in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire Dutch Eating Behavior Questionnaire - DEBQ.
Evolution of pain in Parkinson's disease1 dayEvolution of pain in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire NPSI (Neuropathic Pain Symptom Inventory).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026