IMPACT: Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT03141944

Collaborator

(none)

Enrollment

Locations

36.5

Actual Duration (Months)

22.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Apathy	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 Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Feb 23, 2017

Actual Primary Completion Date :

Mar 11, 2020

Actual Study Completion Date :

Mar 11, 2020

Arms and Interventions

Arm	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"

Arm

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"

Outcome Measures

Primary Outcome Measures

Evolution of apathy in Parkinson's disease [1day]
Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

33 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital of Grenoble	Grenoble	France	38043
2	Hôpital Neurologique Pierre Wertheimer	Lyon	France
3	Centre Expert Régional pour la maladie de Parkinson	Poitiers	France
4	Hôpital de Hautepierre	Strasbourg	France

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Anna CASTRIOTO, MD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT03141944

Other Study ID Numbers:

38RC16.184

First Posted:

May 5, 2017

Last Update Posted:

Mar 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Grenoble

non motor symptoms

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Mar 29, 2021