Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

Parkinson Disease Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141944
• Other study ID #: 38RC16.184
• Status: Completed
• Start date: February 23, 2017
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 33 Years to 72 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apathy
• Parkinson Disease

Intervention

Other:
• Starkstein scale of Apathy
The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble
France	Hôpital Neurologique Pierre Wertheimer	Lyon
France	Centre Expert Régional pour la maladie de Parkinson	Poitiers
France	Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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