Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360009
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2006-08-02
Brief Title:
Effects of Deep Brain Stimulation on Motor Mood and Cognitive Symptoms in Parkinsons Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Cognition and Mood in Parkinsons Disease PD in Subthalamic Nucleus STN Versus Globus Pallidus Interna GPi Deep Brain Stimulation DBS
Status:
COMPLETED
Status Verified Date:
2012-10
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 purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinsons disease
Detailed Description:
Deep brain stimulation DBS of the subthalamic nucleus STN and the globus pallidus interna GPi has been shown to relieve the motor symptoms of Parkinsons disease PD such as tremor rigidity and bradykinesia However there is increasing evidence that DBS may be associated with a significant number of mood and cognitive changes
The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition
In the study researchers will compare motor mood and cognitive function in people with PD who have had DBS treatment with control subjects or individuals with PD who have not had DBS The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target STN and GPi compare the targets and examine the role of lead location
The study will enroll 62 participants-10 control subjects individuals with PD who have not had DBS and 52 individuals with PD who are scheduled for DBS the site of the implant STN or GPi will be randomly assigned Participants will perform motor mood and cognitive tests following 6 months of stimulation over a 2-day period Duration of the trial for participants is 6 months and includes a 2-night hospital stay
Findings from this study may help researchers better understand how DBS affects non-motor circuitry
The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition
In the study researchers will compare motor mood and cognitive function in people with PD who have had DBS treatment with control subjects or individuals with PD who have not had DBS The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target STN and GPi compare the targets and examine the role of lead location
The study will enroll 62 participants-10 control subjects individuals with PD who have not had DBS and 52 individuals with PD who are scheduled for DBS the site of the implant STN or GPi will be randomly assigned Participants will perform motor mood and cognitive tests following 6 months of stimulation over a 2-day period Duration of the trial for participants is 6 months and includes a 2-night hospital stay
Findings from this study may help researchers better understand how DBS affects non-motor circuitry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23NS044997 | NIH | None | httpsreporternihgovquickSearchK23NS044997 |