Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-26 @ 12:29 PM
Study NCT ID:
NCT06389903
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2023-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease
Sponsor:
Centre Hospitalier du Rouvray
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSYLES-STIM
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).
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).
Detailed Description:
The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: