Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358189
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2006-07-28
Brief Title:
Effects of Deep Brain Stimulation for the Treatment of Parkinsons Disease
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Deep Brain Stimulation and Motor Function in Parkinsons Patients
Status:
COMPLETED
Status Verified Date:
2006-07
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 study is to assess the effects of unilateral deep brain stimulation on upper and lower extremity motor function in advanced Parkinsons disease patients It is hypothesized the unilateral stimulation will lead to improvements in bilateral motor functioning
Detailed Description:
Parkinsons disease PD is a chronic progressive degenerative illness in which dopaminergic neurons in the substantia nigra pars compacta deteriorate resulting in a reduction in striatal dopamine Decreased levels of dopamine in PD patients results in varying combinations of akinesia bradykinesia tremor rigidity and gaitpostural instability Parkinsons disease is the second most common neurodegenerative disorder affecting nearly 12 million Americans with annual treatment costs approaching 25 billion Deep brain stimulation DBS is a surgical approach developed for the treatment of advanced PD that provides promise in alleviating its motor deficits The most common stimulation site for the treatment of advanced PD is the subthalamic nucleus STN Nearly 90 percent of patients involved in a multi-center trial with STN stimulation underwent single session bilateral implantation It is generally accepted that bilateral STN stimulation improves upper and lower extremity function However bilateral STN stimulation may be associated with postoperative morbidity including cognitive deficits and neuropsychiatric changes In contrast the effects of unilateral STN stimulation on bilateral upper and lower extremity motor function are poorly understood The question of whether to proceed with bilateral or unilateral surgery is important as a significant number of patients for whom surgery is a consideration have relative contraindications such as age greater than 70 cognitive decline or other medical conditions that may prevent bilateral implantation Considering the risks for bilateral implantation may be greater than unilateral procedures it is necessary to determine if unilateral stimulation is an effective means of ameliorating PD symptoms The primary aim of this collaborative project is to determine the effects of unilateral STN DBS on functional upper manual dexterity and lower postural stability and gait initiation extremity motor performance in Veterans with advanced PD The results from these studies have the potential to impact the use of DBS in the treatment of advanced PD Positive bilateral results with unilateral stimulation of STN may allow patients not currently considered eligible for bilateral implantation to be considered for unilateral procedures as a method of treating PD symptoms Our general hypothesis is that unilateral STN DBS acts to override disrupted neural activity of the basal ganglia in one hemisphere The resultant normalized basal ganglia output to the SMA then allows for improved planning and control of bilateral actions Bilateral upper and lower extremity motor performance will be quantified in a group of advanced PD patients with unilateral STN DBS patients while on and off stimulation It is hypothesized that unilateral STN DBS will result in bilateral improvements in upper and lower extremity motor function
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