Deep TMS of Neural Circuits Associated With Stimulant Use Disorder
- Conditions
- Methamphetamine Use DisorderTranscranial Magnetic Stimulation
- Interventions
- Device: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - ShamDevice: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active
- Registration Number
- NCT06578429
- Lead Sponsor
- Stanford University
- 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 7/8 (87.5%) studies using TMS for MUD or 38/50 (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 excitatory/inhibitory 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 (e.g., up to 17 cubic centimeters) as well as a deeper area (e.g., 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham dTMS Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham Participants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total. Active dTMS Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active Participants will receive 30 active dTMS treatments, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.
- Primary Outcome Measures
Name Time Method Insula Function 1-4 days post-treatment The primary measure of SN function will include insula activation during the monetary incentive delay task, anticipation of loss contrasted with no loss
Percentage of Days Abstinent 3 months post-treatment Methamphetamine use outcomes will be assessed using the TimeLine Follow Back (TLFB) Method, which utilizes calendar cue to recall recent, self-reported substance use, combined with objective biomarker data
- Secondary Outcome Measures
Name Time Method Binary Relapse 3 months post-treatment Binary (yes/no) relapse after treatment via self-report
Other Salience Network Function 1-4 days post-treatment The secondary measures of SN function will include insula to PFC functional connectivity, and dACC to insula functional connectivity using the same task as the primary measure.
Resting-State Salience Network 1-4 days post-treatment The investigators will also utilize whole-brain, voxel-wise analyses for the task with stringent error correction, as well as insula activation and insula to dACC functional connectivity during resting state fMRI.
Trial Locations
- Locations (1)
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States