Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease (IMPACT)

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Apathy
• Intervention / Treatment: Other: Starkstein scale of Apathy

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University hospital of Grenoble
  • Lyon, France
    • Hôpital Neurologique Pierre Wertheimer
  • Poitiers, France
    • Centre Expert Régional pour la maladie de Parkinson
  • Strasbourg, France
    • Hôpital de HAUTEPIERRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinon's disease who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667 between june 2012 and june 2016

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apathetic patients; De novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"	Other: Starkstein scale of Apathy; The degree of apathy will be evaluated with the "Starkstein scale of Apathy"
Non-apathetic patients; De novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"	Other: Starkstein scale of Apathy; The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of apathy in Parkinson's disease	Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of hypodopaminergia in Parkinson's disease	Evolution 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.	1 day
Apparition of hyperdopaminergic symptoms in Parkinson's disease	Apparition 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.	1 day
Evolution of impulsivity in Parkinson's disease	Evolution of impulsivity in patients with Parkinson's disease under dopaminergic treatment. Evaluation with a self-assessment-questionnaire (UPPS Impulsive Behavior Scale)	1 day
Evolution of personality in Parkinson's disease	Evolution of personality in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire "Temperament and Character Inventory" (TCI).	1 day
Evolution of pain in Parkinson's disease	Evolution of pain in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire NPSI (Neuropathic Pain Symptom Inventory).	1 day
Evolution of quality of life in Parkinson's disease	Evolution of quality of life in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire PDQ39 (Parkinson's disease questionnaire).	1 day
Evolution of somnolence in Parkinson's disease	Evolution of somnolence in patients with Parkinson's disease under dopaminergic treatment with the ECMP scale.	1 day
Evolution of eating behavior in Parkinson's disease	Evolution of eating behavior in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire "Dutch Eating Behavior Questionnaire" - DEBQ.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Anna Castrioto, MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2017
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: non motor symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 38RC16.184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No