NCT03793491

Brief Summary

The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

December 21, 2018

Last Update Submit

January 3, 2019

Conditions

Parkinson Disease

Keywords

continuous infusionpersonality

Outcome Measures

Primary Outcomes (2)

  • percent of improvement of quality of life score at 6 months after the beginning of the second line treatment

    Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment

    day 1

  • percent of improvement of quality of life score at 6 months after the beginning of the second line treatment

    Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment

    6 months

Study Arms (1)

Patients having Parkinson's disease

Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale.

Other: TCI scaleOther: PDQ-39 scale

Interventions

TCI scaleOTHER

TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.

Also known as: Temperament and Character Inventory scale (TCI), Quality of life scale
Patients having Parkinson's disease
PDQ-39 scaleOTHER

PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.

Also known as: Parkinson's Disease Questionnaire (PDQ-39)
Patients having Parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson patients

You may qualify if:

  • Patients having Parkinson's disease according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
  • All Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease
  • Patient able to give its free and informed consent
  • Patient having a social security

You may not qualify if:

  • Patients presenting atypical Parkinson's syndrome
  • Patients having a deep brain stimulation
  • Patient having a psychiatric disease such as: mood disorders, psychotic disorder…
  • Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24
  • None ability to give its consent
  • Patients unable to realize the tests provided in the context of this study
  • Patients under supervision, curators, or legal guardian
  • Patients non-affiliated to a social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Chrisitine BREFEL COURBON, PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 4, 2019

Study Start

December 18, 2018

Primary Completion

December 18, 2020

Study Completion

June 18, 2021

Last Updated

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)