Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's Disease

NCT ID: NCT04933513

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2023-08-30

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

preoperative Parkinson' disease

pre DBS parkinson's disease patients responding to the DBS-PS scale preoperatively

pre DBS patients responding to the DBS-PS scale

Intervention Type: BEHAVIORAL

we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively

Interventions

pre DBS patients responding to the DBS-PS scale

we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parkinson's disease patients included in the Predistim study and having completed the DBS-PS scale during the preoperative phase

Exclusion Criteria

• Parkinson's disease patients not included in the Predistim study or not having completed the DBS-PS scale during the preoperative phase

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Mme Mylène MEYER

psychologist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU de Nancy

Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38908172 (View on PubMed)

Other Identifiers

2020PI179

Identifier Type: -

Identifier Source: org_study_id