Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405074
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-11-16
Brief Title:
Low Intensity Focused Ultrasound for Tobacco Use Disorder High Resolution Targeting of the Human Insula
Sponsor:
Washington DC Veterans Affairs Medical Center
Organization:
Washington DC Veterans Affairs Medical Center
Study Overview
Official Title:
Low Intensity Focused Ultrasound for Tobacco Use Disorder High Resolution Targeting of the Human Insula
Status:
RECRUITING
Status Verified Date:
2024-05
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_TUD
Brief Summary:
The goal of this clinical trial is to to inhibit the dorsal anterior insula dAI with low intensity focused ultrasound LIFU to determine the causal role for the dAI in smoking cue induced craving in individuals with tobacco use disorder TUD smoking cue induced craving is a clinically important behavior which has been associated with the severity of nicotine addiction The main questions it aims to answer are
the safety and tolerability of dAI LIFU compared to sham stimulation in individuals with TUD
the effects of LIFU vs sham to left dAI functional magnetic resonance imaging fMRI BOLD activity and craving in response to smoking cue exposure
Participants will undergo anatomical MRI neurological assessment clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham
Participants will undergo functional magnetic resonance imaging where we will measure the effect of LIFU vs sham on 1 dAI blood-oxygen-level-dependent BOLD activation in response to smoking compared to neutral cue exposure and 2 cue-induced craving in individuals with TUD Each participant will receive LIFU and sham stimulation
the safety and tolerability of dAI LIFU compared to sham stimulation in individuals with TUD
the effects of LIFU vs sham to left dAI functional magnetic resonance imaging fMRI BOLD activity and craving in response to smoking cue exposure
Participants will undergo anatomical MRI neurological assessment clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham
Participants will undergo functional magnetic resonance imaging where we will measure the effect of LIFU vs sham on 1 dAI blood-oxygen-level-dependent BOLD activation in response to smoking compared to neutral cue exposure and 2 cue-induced craving in individuals with TUD Each participant will receive LIFU and sham stimulation
Detailed Description:
Tobacco use disorder TUD remains the leading cause of preventable death in the world Costs of smoking related illness in the United States totals more than 300 billion each year The majority of adult cigarette smokers want to quit and more than half make an attempt but fewer than 1 in 10 smokers successfully quit at the end of 1 year Rates of cigarette smoking are higher and cessation rates are lower in the veteran population in the United States compared to the nonveteran population Noninvasive neuromodulation holds promise as a therapeutic approach to TUD as evidenced by the recent food and drug administration FDA clearance of deep transcranial magnetic stimulation TMS as such a treatment One additional emerging potential therapeutic is using low-intensity focused ultrasound LIFU to inhibit cortical and deep brain regions The enormous potential of LIFU stems from the ability to focus ultrasound through the intact skull to a millimeter-sized focal spot size anywhere in the brain This makes it a powerful alternative to both invasive neurosurgical procedures and other noninvasive brain stimulation techniques such as TMS that have limited spatial resolution and can only reach superficial areas of the brain One promising target to treat TUD is the dorsal anterior insular cortex dAI a brain structure whose function is linked to the desire to smoke The dAI is a part of the salience network SN that is involved in assigning significance and emotional value to stimuli and is consistently activated with exposure to smoking cues and craving Remarkably humans with damage to the insula were able to stop smoking easily and without experiencing cravings or relapse As such the insula is a promising target for reducing craving and use in individuals with TUD Unfortunately the dAI is small and lies deep within the lateral sulcus covered by the overlying opercula of the temporal lobe and is not accessible with conventional noninvasive neuromodulatory techniques LIFU can selectively target the dAI and provides a potentially transformative method to reduce nicotine craving and addiction The overall purpose of this proposal is to inhibit the dAI with LIFU to determine the causal role for the dAI in smoking cue induced craving which is a clinically important behavior which has been associated with the severity of nicotine addiction
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?:
False
Is an FDA AA801 Violation?:
None