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

Parkinson's Disease Clinical Trial

— TeSLa-PD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05072015
• Other study ID #: 8355
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: March 2028

Study information

• Verified date: January 2022
• Source: University Hospital, Strasbourg, France
• Contact: Mathieu ANHEIM
• Phone: +33 3 88 12 85 35
• Email: mathieu.anheim[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2028
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
France	Mathieu ANHEIM	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement	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