Parkinson's DiseaseNCT04933513
Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's Disease
An observational study of Parkinson's Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- pre DBS patients responding to the DBS-PS scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2022to 30 Aug 2023
- 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: - Parkinson's disease patients selected for STN DBS and participating to the Predistim study
Who may be able to join
- Parkinson's disease patients included in the Predistim study and having completed the DBS-PS scale during the preoperative phase
Who cannot join
- Parkinson's disease patients not included in the Predistim study or not having completed the DBS-PS scale during the preoperative phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)
Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.
- Conditions
- Parkinson's Disease
- Being tested
- pre DBS patients responding to the DBS-PS scale
- Keywords
- deep brain stimulation, preoperative expectations, DBS-PS, validation, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre DBS patients responding to the DBS-PS scaleBehavioural
we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively
| Study group | Role | What they receive |
|---|---|---|
| preoperative Parkinson' disease | pre DBS parkinson's disease patients responding to the DBS-PS scale preoperatively Receives: Behavioral: pre DBS patients responding to the DBS-PS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Deep-brain stimulation - perception scale (DBS-PS scale)
Deep Brain Stimulation-Perception Scale completed by Parkinson's disease patients enrolled in the Predistim study; minimum scale score 0 - maximum scale score 50, for each sub-scores (3 dimensions) ; a higher score corresponding to higher expectations in the dimension, and a lower score coresponding to lower expectations in the dimension
Measured: during the inclusion/baseline period of Predistim study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start30 Mar 2022
- Primary completion30 Mar 2022
- Study completion30 Aug 2023
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's DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Poitiers University Hospital, Assistance Publique - Hôpitaux de Paris, University Hospital, Lille
- Responsible party
- Principal investigator, Mme Mylène MEYER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933513
- Sponsor's protocol ID
- 2020PI179
- Status last verified
- Feb 2024
- First submitted
- 8 Jun 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meyer M, Spitz E, Colnat-Coulbois S, Benatru I, Guehl D, Hainque E, Rolland AS, Corvol JC, Devilliers H, Schwan R, Devos D; PREDISTIM group. Development and validation of the DBS-PS (Deep Brain Stimulation-Perception Scale): Assessing parkinsonian patients' expectations to prevent post-operative disappointment? J Neurol Sci. 2024 Jul 15;462:123093. doi: 10.1016/j.jns.2024.123093. Epub 2024 Jun 13.
PubMed 38908172
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)
- ClinicalTrials.gov ID
- NCT04933513
- Acronym / sponsor ID
- 2020PI179
- Conditions
- Parkinson's Disease
- Keywords
- deep brain stimulation, preoperative expectations, DBS-PS, validation, Parkinson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Poitiers University Hospital, Assistance Publique - Hôpitaux de Paris, University Hospital, Lille
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 21 Jun 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.
Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative Parkinson' disease | – | Behavioral: pre DBS patients responding to the DBS-PS scalepre DBS parkinson's disease patients responding to the DBS-PS scale preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Parkinson's disease patients selected for STN DBS and participating to the Predistim study
Key inclusion criteria (1 listed)
- Parkinson's disease patients included in the Predistim study and having completed the DBS-PS scale during the preoperative phase
Key exclusion criteria (1 listed)
- Parkinson's disease patients not included in the Predistim study or not having completed the DBS-PS scale during the preoperative phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre DBS patients responding to the DBS-PS scalewe propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively | Behavioural | preoperative Parkinson' disease |
Primary outcome
Validation of the Deep-brain stimulation - perception scale (DBS-PS scale)
Time frame: during the inclusion/baseline period of Predistim study
Deep Brain Stimulation-Perception Scale completed by Parkinson's disease patients enrolled in the Predistim study; minimum scale score 0 - maximum scale score 50, for each sub-scores (3 dimensions) ; a higher score corresponding to higher expectations in the dimension, and a lower score coresponding to lower expectations in the dimension
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 12 Feb 2024.
- Derived from this study: PubMed 38908172Meyer M, Spitz E, Colnat-Coulbois S, Benatru I, Guehl D, Hainque E, Rolland AS, Corvol JC, Devilliers H, Schwan R, Devos D; PREDISTIM group. Development and validation of the DBS-PS (Deep Brain Stimulation-Perception Scale): Assessing parkinsonian patients' expectations to prevent post-operative disappointment? J Neurol Sci. 2024 Jul 15;462:123093. doi: 10.1016/j.jns.2024.123093. Epub 2024 Jun 13.
- 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's Disease, run by Central Hospital, Nancy, 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 1 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 12 Feb 2024. 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?
Validation of the Deep-brain stimulation - perception scale (DBS-PS scale) (time frame: during the inclusion/baseline period of Predistim study). 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 NCT04933513, 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 12 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.