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NCT Number: NCT05072015

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mathieu ANHEIM

Strasbourg, 67098, France

Location contact

Christine TRANCHANT

SUB_INVESTIGATOR

Mathieu ANHEIM

CONTACT

[email protected]

+33388128535

Mathieu ANHEIM

PRINCIPAL_INVESTIGATOR

Ouhaid LAGHA BOUKBIZA

SUB_INVESTIGATOR

Thomas WIRTH

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mathieu ANHEIM

CONTACT

[email protected]

+33 3 88 12 85 35

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: TeSLa-PD

Important dates

Study start
2022
Primary completion
2022
Study completion
2028
First posted
Oct 8, 2021
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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