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Starting soon Observational

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

NCT05072015 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-02
Last updated
2022-02-17

Condition(s) studied

Parkinson's Disease

Study summary

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

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement — 1 year
    Evaluate the evolution of motor fluctuations and dyskinesias at one year in patients. treated with one of the 3 TSLs (bilateral stimulation of the subthalamic nucleus, apomorphine pump and duodopa pump. the higher the score, the more the disease is installed

Trial sites (1)

FacilityCityRegionStatus
Mathieu ANHEIM Strasbourg France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05072015 on ClinicalTrials.gov ↗ ← All trials in France