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

February 1, 2022 updated by: University Hospital, Strasbourg, France

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67098
        • Mathieu ANHEIM
        • Principal Investigator:
          • Mathieu ANHEIM
        • Contact:
        • Sub-Investigator:
          • Christine TRANCHANT
        • Sub-Investigator:
          • Ouhaid LAGHA BOUKBIZA
        • Sub-Investigator:
          • Thomas WIRTH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced Parkinson' s disease who need second line treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Mathieu ANHEIM, Les Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2028

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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