Parkinson's DiseaseTeSLa-PDNCT05072015
Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)
An observational study of Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2022to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced Parkinson' s disease who need second line treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Mathieu ANHEIM
Strasbourg, 67098
Mathieu ANHEIM, +33388128535, mathieu.anheim@chru-strasbourg.fr
Mathieu ANHEIM
About this study
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
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study startFeb 2022 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu ANHEIM, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072015
- Sponsor's protocol ID
- 8355
- Acronym
- TeSLa-PD
- Status last verified
- Jan 2022
- First submitted
- 30 Sep 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)
- ClinicalTrials.gov ID
- NCT05072015
- Acronym / sponsor ID
- TeSLa-PD / 8355
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced Parkinson' s disease who need second line treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu ANHEIM principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu ANHEIM (+33 3 88 12 85 35, mathieu.anheim@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.