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

Not yet recruiting

• Conditions: Parkinson's Disease

• Registration Number: NCT05072015
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-08
• Status Verified: 2022-01
• Study Start: 2022-02
• Primary Completion: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-17
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Mathieu ANHEIM; 🇫🇷 Strasbourg, France