Sponsor study identifier
observational
22
1 country
1
Study Start
March 30, 2022
Actual (reported)Primary Completion
March 30, 2022
Actual (reported)Study Completion
August 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2021
Actual (reported)June 21, 2021
Actual (reported)March 30, 2022
Actual (reported)March 30, 2022
Actual (reported)August 30, 2023
Actual (reported)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
during the inclusion/baseline period of Predistim study
pre DBS parkinson's disease patients responding to the DBS-PS scale preoperatively
we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
\- Parkinson's disease patients selected for STN DBS and participating to the Predistim study
CHU de Nancy
Nancy, 54000, France
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.
22 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2021
First Posted
June 21, 2021
Study Start
March 30, 2022
Actual (reported)Combined Deep Brain Stimulation in Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
March 30, 2022
Actual (reported)Study Completion
August 30, 2023
Actual (reported)Last Updated
February 12, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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