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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05072015
Acronym
TeSLa-PD
Enrollment
150
Registered
2021-10-08
Start date
2022-02-28
Completion date
2028-03-31
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement1 yearEvaluate 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

Countries

France

Contacts

Primary ContactMathieu ANHEIM
mathieu.anheim@chru-strasbourg.fr+33 3 88 12 85 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026