Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389903
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2023-10-06
Brief Title:
Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinsons Disease
Sponsor:
Centre Hospitalier du Rouvray
Organization:
Centre Hospitalier du Rouvray
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 Parkinsons 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 Parkinsons disease patients requiring deep brain stimulation implantation
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinsons 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 Parkinsons 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 Parkinsons 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:
None
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?:
None