Parkinson DiseaseNSTBOSNCT05103072
Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage
An observational study of Parkinson Disease and Subthalamic Nucleus Stimulation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient. The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Subthalamic Nucleus Stimulation, Directional Electrodes
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is a non interventional retrospective study. Data were collected before and after surgery of subthalamic nucleus stimulation of patients with Parkinson Disease.
Who may be able to join
- age : >18Y
- All patient with Parkinson disease eligible for sub thalamic surgery (CAPSIT criterias) in CHU AMIENS
Who cannot join
- patient doesn't consent
Trial locations and contacts
1 site in 1 country.
About this study
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.
The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.
The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.
The investigators would like to study the non inferiority of this tool to choose the best plot .
- Keywords
- Parkinson Disease, Subthalamic nucleus stimulation, directional electrodes
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| testing all the plots | the investigator chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator (" plot by plot ") | |
| Guide X Software | the investigator can chose the plot using a software (Guide Xt), which can delete the exhausting test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of MDS UPDRS 3 score
The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications.
The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications.Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start27 Jul 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103072
- Sponsor's protocol ID
- PI2021_843_0162
- Acronym
- NSTBOS
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aubignat M, Berro A, Tir M, Lefranc M. Imaging-Guided Subthalamic Nucleus Deep Brain Stimulation Programming for Parkinson Disease: A Real-Life Pilot Study. Neurol Clin Pract. 2024 Dec;14(6):e200326. doi: 10.1212/CPJ.0000000000200326. Epub 2024 Sep 11.
PubMed 39282508
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage
- ClinicalTrials.gov ID
- NCT05103072
- Acronym / sponsor ID
- NSTBOS / PI2021_843_0162
- Keywords
- Parkinson Disease, Subthalamic nucleus stimulation, directional electrodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Nov 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.
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.
The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.
The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.
The investigators would like to study the non inferiority of this tool to choose the best plot .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testing all the plots | – | –the investigator chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator (" plot by plot ") |
| Guide X Software | – | –the investigator can chose the plot using a software (Guide Xt), which can delete the exhausting test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is a non interventional retrospective study. Data were collected before and after surgery of subthalamic nucleus stimulation of patients with Parkinson Disease.
Key inclusion criteria (2 listed)
- age : >18Y
- All patient with Parkinson disease eligible for sub thalamic surgery (CAPSIT criterias) in CHU AMIENS
Key exclusion criteria (1 listed)
- patient doesn't consent
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
Increase of MDS UPDRS 3 score
Time frame: 3 months
The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications.Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 39282508Aubignat M, Berro A, Tir M, Lefranc M. Imaging-Guided Subthalamic Nucleus Deep Brain Stimulation Programming for Parkinson Disease: A Real-Life Pilot Study. Neurol Clin Pract. 2024 Dec;14(6):e200326. doi: 10.1212/CPJ.0000000000200326. Epub 2024 Sep 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease and Subthalamic Nucleus Stimulation, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of MDS UPDRS 3 score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103072, which also lists 1 linked publication.
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 24 Jun 2026.