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

March 26, 2021 updated by: University Hospital, Grenoble

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

29 years to 68 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evolution of apathy in Parkinson's disease
Time Frame: 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".
1day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of hypodopaminergia in Parkinson's disease
Time Frame: 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.
1 day
Apparition of hyperdopaminergic symptoms in Parkinson's disease
Time Frame: 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.
1 day
Evolution of impulsivity in Parkinson's disease
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 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).
1 day
Evolution of somnolence in Parkinson's disease
Time Frame: 1 day
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
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Castrioto, MD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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