Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903495
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2023-05-11
Brief Title:
Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Sponsor:
West Virginia University
Organization:
West Virginia University
Study Overview
Official Title:
A Randomized Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical study is to investigate the safety tolerability and feasibility of Deep Brain Stimulation DBS of the nucleus accumbens NAc and ventral internal capsule VC for participants with treatment refractory opioid use disorder OUD who have cognitive behavioral and functional disability
Detailed Description:
The overarching goal of this study is to evaluate the safety tolerability feasibility and impact on outcomes of NAcVC DBS for treatment refractory OUD In treatment refractory OUD innovative approaches and more invasive interventions including DBS are warranted to improve outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None