Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498349
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-17
Brief Title:
Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Sponsor:
University of Kiel
Organization:
University of Kiel
Study Overview
Official Title:
A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinsons Disease and Impulse Control Disorders
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The focus of the study is on patients Parkinsons disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder ICD Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinsons disease The goal of this academic study is to compare the effect of surgical deep brain stimulation DBS treatment combined with a coordinated and adapted best medical treatment BMT to be compared with the effect of optimized best medical treatment BMT alone The stimulation arm DBSBMT as well as the medication arm BMT only will be monitored according to clinical routine Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment DBS group or the best medical treatment alone BMT group Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study
Detailed Description:
None
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