Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00954421
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2009-07-27
Brief Title:
Use of Two Deep Brain Stimulation DBS Electrodes to Treat Post-Traumatic Tremor
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Use of Two DBS Electrodes to Treat Post-Traumatic Tremor
Status:
COMPLETED
Status Verified Date:
2014-07
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 research study is to
1 Determine whether deep brain stimulation DBS with two leads very thin coiled wires placed unilaterally on one side of the brain is beneficial to patients with multiple sclerosis MS tremor
2 Compare the two different locations of the DBS lead placement in effectiveness for treatment of muscle tremors that do not respond to treatment with medication caused by multiple sclerosis
3 Evaluate any side effects that may result from the two DBS leads
1 Determine whether deep brain stimulation DBS with two leads very thin coiled wires placed unilaterally on one side of the brain is beneficial to patients with multiple sclerosis MS tremor
2 Compare the two different locations of the DBS lead placement in effectiveness for treatment of muscle tremors that do not respond to treatment with medication caused by multiple sclerosis
3 Evaluate any side effects that may result from the two DBS leads
Detailed Description:
Surgical treatment of disabling multiple sclerosis MS tremor that does not respond to medication has proven difficult To date there have been no prospective blinded studies to evaluate efficacy of surgical treatments for these tremors Based on prior data this study will examine the use of 2 DBS electrodes on the same side of the brain in the thalamus region one at an area referred to as the ventralis intermedius nucleusventralis oralis posterior nucleus border or VIM and one at a region called the ventralis oralis anterior nucleusventralis oralis posterior nucleus border or VO for treatment of MS tremor This study will test the effectiveness of VIM combined with and independent of VO DBS and characterize safety benefits and side effects of this procedure for treatment of MS-related tremors
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 |
|---|---|---|---|
| K23NS052557 | NIH | None | httpsreporternihgovquickSearchK23NS052557 |