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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04933513

Collaborator

University Hospital, Bordeaux (Other), Poitiers University Hospital (Other), Assistance Publique - Hôpitaux de Paris (Other), University Hospital, Lille (Other)

Enrollment

Location

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Behavioral: pre DBS patients responding to the DBS-PS scale

Study Design

Study Type:

Observational

Anticipated Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Mar 30, 2022

Actual Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
preoperative Parkinson' disease pre DBS parkinson's disease patients responding to the DBS-PS scale preoperatively	Behavioral: 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

Arm

Intervention/Treatment

preoperative Parkinson' disease

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

Behavioral: 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

Outcome Measures

Primary Outcome Measures

Validation of the Deep-brain stimulation - perception scale (DBS-PS scale) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nancy	Nancy		France	54000

Sponsors and Collaborators

Central Hospital, Nancy, France
University Hospital, Bordeaux
Poitiers University Hospital
Assistance Publique - Hôpitaux de Paris
University Hospital, Lille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mme Mylène MEYER, psychologist, PhD, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT04933513

Other Study ID Numbers:

2020PI179

First Posted:

Jun 21, 2021

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mme Mylène MEYER, psychologist, PhD, Central Hospital, Nancy, France

deep brain stimulation

preoperative expectations

DBS-PS

validation

Parkinson's disease

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jul 21, 2022