Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease
PSYLES-STIM
Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
1 other identifier
interventional
15
1 country
1
Brief Summary
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation. The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jun 2019
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2021
CompletedFirst Submitted
Initial submission to the registry
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedApril 29, 2024
April 1, 2024
1.1 years
October 6, 2023
April 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of change of mania symptoms
The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
Baseline, 72 hours, 1 month and 3 months after surgery
Secondary Outcomes (7)
Assessment of change of depressive symptoms
Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Behavior
Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Impulsivity
Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Apathy
Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of personality
Baseline
- +2 more secondary outcomes
Study Arms (1)
Behavorial Assessment
EXPERIMENTALpost-surgery behavioral assessment using scales
Interventions
Eligibility Criteria
You may qualify if:
- Major patient
- Diagnosis of Parkinson's disease (ICD-10)
- L-dopa test must be positive
- Participants who gave their informed, written consent
You may not qualify if:
- Severe psychiatric disorder
- Major neurocognitive disorder contraindicating surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marie Desbordes, MD
Sotteville-lès-Rouen, 76300, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2023
First Posted
April 29, 2024
Study Start
June 4, 2019
Primary Completion
July 3, 2020
Study Completion
October 5, 2021
Last Updated
April 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share