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Not yet recruiting NCT05072015

Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

Observational Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson's Disease. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump Secundary purposes: * Motor complications evolution at 6 months, 2 and 3 years * MDS UPDRS III score at 6 months, 1, 2 and 3 years * non motor complications evolution at 6 months, 1, 2 and 3 years * cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years * cutaneous and digestive complications at 6 months, 1, 2 and 3 years * neuropathy occurrence at 6 months, 1, 2 and 3 years * medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years

Primary outcome measures

  • MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Parkinson disease (UKPDSSB criteria)
  • Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump
  • MOCA >20
  • patient >21 years of age
  • patient who has signed protocol acceptation

Exclusion criteria

  • patient who did not give his acceptation for the protocol
  • patient with another parkinsonian syndrome than Parkinson' s disease
  • MOCA<20
  • Patient who does not need second line treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Mathieu ANHEIM — Strasbourg

Identifiers

NCT: NCT05072015 · 8355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗