Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
Sponsor:
VA Palo Alto Health Care System
Organization:
VA Palo Alto Health Care System
Study Overview
Official Title:
Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
Status:
NOT_YET_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:
None
Brief Summary:
Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States constituting a humanitarian crisis with substantial financial burden on society and medical facilities While several pharmacological interventions exist 60 of individuals who seek these treatments relapse to alcohol within 6 months These high relapse rates are due in part to elevated brain response to alcohol cues in the environment This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging fMRI guided transcranial magnetic stimulation TMS as a strategy to reduce brain reactivity to alcohol cues
Detailed Description:
At least 60 of those with AUD will experience a major relapse period within 6 months of treatment irrespective of the intervention psychosocial andor pharmacological employed Consequently the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the VA Health Care System Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy which is reflected in the high rate of relapse in AUD Transcanial Magnetic Stimulation TMS is a neurostimulation method that is at the forefront of innovative non-invasive and safe treatments for AUD and other psychiatric disorders To reduce the high rate of relapse in Veterans with AUD it is necessary for interventions to more effectively address the associated neurobiological dysfunction Non-invasive neuromodulation techniques are showing promise toward the aim of modifying specific and selective neural targets related to AUD and relapse To date TMS has been primarily delivered to the dorsolateral and medial prefrontal cortices as these regions are on average highly reactive to alcohol cues On an individual basis however peak brain response to alcohol cues can vary substantially in spatial location within the brain Retrospective analyses of TMS-AUD clinical trails has demonstrated that when TMS is delivered to an individuals peak brain response to alcohol cues the likelihood of remaining abstinent is increased by a factor of 56 relative to sham TMS treatment This study aims to deliver one session of TMS to a cortical target which displays peak functional connectivity to the ventral striatum a key brain region mediating reward and alcohol cue reactivity The ultimate goal of this study evaluate change in brain reactivity to alcohol cues following active and sham TMS
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