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Completed

NCT Number: NCT03141944

Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

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

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Key information

Conditions

Parkinson Disease Apathy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Lethargy Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

33 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Starkstein scale of Apathy

Other

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

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 5, 2017
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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