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Completed

NCT Number: NCT04933513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre DBS patients responding to the DBS-PS scale

Behavioral

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Poitiers University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Lille

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 21, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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