Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453109
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Focused Ultrasound for the Complex Patient
Sponsor:
Washington DC Veterans Affairs Medical Center
Organization:
Washington DC Veterans Affairs Medical Center
Study Overview
Official Title:
Towards Treatment of the Complex Patient Investigations of Low-intensity Focused Ultrasound
Status:
RECRUITING
Status Verified Date:
2024-07
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:
LIFU
Brief Summary:
The goal of this clinical trial is to to inhibit the anterior insula AI with low intensity focused ultrasound LIFU to determine the causal role for the AI in pain processing anxiety and opiate cue-induced craving The main questions it aims to answer are
the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder OUD anxiety and chronic back pain
the effects of LIFU vs sham on measures of pain processing anxiety symptoms and opiate cue-induced craving
Participants will undergo anatomical MRI neurological assessment clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham
the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder OUD anxiety and chronic back pain
the effects of LIFU vs sham on measures of pain processing anxiety symptoms and opiate cue-induced craving
Participants will undergo anatomical MRI neurological assessment clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham
Detailed Description:
Opioid use disorder with co-morbid chronic pain and anxiety is a clinical triad associated with the highest risk of opiate overdose deaths Co-occurrence of these three disorders amplifies symptoms of each and results in poorer treatment outcomes There are shared neurobiological substrates for these disorders such as reward processing and stress response The anterior insula AI is a brain region involved in these processes as well as in clinical disorder of pain addiction and anxiety The AI is upregulated in pain addiction and anxiety disorders and is therefore a potential therapeutic target for neuromodulation Low-intensity focused ultrasound LIFU is a noninvasive method to inhibit cortical and deep brain regions LIFU can reach deep brain regions such as the AI with spatial specificity unlike traditional noninvasive neuromodulation methods which lack spatial specificity and depth penetration LIFU can selectively target the insula and its subregions and provides a potentially transformative method to reduce symptoms of pain opiate craving and anxiety in a complex patient population such as co-morbid chronic pain anxiety and opioid use disorder In this study the investigators will administer one session of inhibitory LIFU to the AI in individuals with opiate use disorder chronic back pain and anxiety disorders generalized anxiety disorder post-traumatic stress disorder or social anxiety disorder The aim of this phase of the study is to establish that LIFU vs sham LIFU to AI is safe and well tolerated as measured by adverse events clinical evaluation and repeated structural brain magnetic resonance imaging scans The investigators will also gather preliminary data on the effect of LIFU to AI on opiate cue-induced craving and laboratory measures of central sensitizationCS which occurs with pain chronicity such as temporal summation of pain and conditioned pain modulation There is a need for improved treatments for complex patients such as co-morbid chronic back pain anxiety and opioid use disorder beyond combining treatments for each disorder LIFU provides an ability to transiently and selectively inhibit AI to determine its causal role in co-morbid chronic back pain anxiety and opioid use disorder symptoms which then may lead to improved treatments for this clinical triad which is associated with poor treatment 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG3DA059407 | NIH | None | httpsreporternihgovquickSearchUG3DA059407 |