Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578429
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Deep TMS of Neural Circuits Associated With Stimulant Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Deep TMS Neuromodulation of Neural Circuits Associated With Stimulant Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study aims to evaluate the efficacy of deep transcranial magnetic stimulation dTMS as a treatment for Veterans with a methamphetamine use disorder MUD
Detailed Description:
To date TMS has emerged as a promising treatment avenue for addiction and is being tested in clinical trials with some encouraging results A recent systematic review and meta-analysis highlights that 78 875 studies using TMS for MUD or 3850 88 in addiction more broadly have targeted the left DLPFC alone While this strategy has been useful in reducing craving treated individuals resume use shortly after treatment at similar rates to those receiving sham Here utilizing a data-driven and innovative approach the investigators aim to modulate target brain function that has been shown to predict treatment outcomes for individuals with MUD The literature describes how TMS treatment is associated with physiological changes in the brain at the target area and in remote structurally or functionally connected brain areas TMS has been associated with changes in long-term potentiation LTP or depression LTD to increase neuroplasticity through increases in brain-derived neurotrophic factor BDNF and implicated in influencing the excitatoryinhibitory balance of GABAergic synapses H-coil designs have the potential to target deeper regions of the brain as well as multiple downstream interacting brain networks in a novel manner For example insula stimulation has the potential to strengthen the salience network broadly and subsequently ameliorate relapse risk
An emerging advancement is the use of coils that target deeper regions of the brain and have the potential of targeting multiple interacting brain networks The H-coil configuration in this technique stimulates a broader area eg up to 17 cubic centimeters as well as a deeper area eg up to 4 cm relative to standard figure-of-eight coils further enhancing innovation and generalizability With this coil the investigators hypothesize modifying the salience network nodes that are otherwise not reached by figure-of-eight coils Notably published studies to date that utilize these H-coils for addiction yield promising results However whether the proposed stimulation strategies will have objectively measurable impact on their respective brain targets or similar impact in individuals with MUD remains unclear
The proposed study fills a critical scientific gap of the need to evaluate a novel non-invasive brain stimulation technique for MUD
The investigators believe this proposed work will provide preliminary data for a larger grant submission that could allow for a more complex study design to fully answer gaps in current knowledge about deep TMS H4 coil as a possible treatment approach for MUD
An emerging advancement is the use of coils that target deeper regions of the brain and have the potential of targeting multiple interacting brain networks The H-coil configuration in this technique stimulates a broader area eg up to 17 cubic centimeters as well as a deeper area eg up to 4 cm relative to standard figure-of-eight coils further enhancing innovation and generalizability With this coil the investigators hypothesize modifying the salience network nodes that are otherwise not reached by figure-of-eight coils Notably published studies to date that utilize these H-coils for addiction yield promising results However whether the proposed stimulation strategies will have objectively measurable impact on their respective brain targets or similar impact in individuals with MUD remains unclear
The proposed study fills a critical scientific gap of the need to evaluate a novel non-invasive brain stimulation technique for MUD
The investigators believe this proposed work will provide preliminary data for a larger grant submission that could allow for a more complex study design to fully answer gaps in current knowledge about deep TMS H4 coil as a possible treatment approach for MUD
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