Deep TMS of Neural Circuits Associated With Stimulant Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorStanford University
About this trial
This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with a methamphetamine use disorder (MUD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be within the age range of 25-75.
Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate to severe MUD (≥4 diagnostic symptoms).
Participants must be able to obtain a Motor Threshold (MT), which will be determined during the screening process.
Participants must have an adequately stable condition and environment to enable attendance at scheduled clinic visits.
Disqualifiers
Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, ferromagnetic metal in the head and body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/object in the head and body within 30 cm of the treatment coil.
General medical condition, disease, or neurological disorder that interferes with the assessments or participation.
Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
Current substance abuse as determined by positive toxicology screen
Trial design
Design model
Parallel
Treatments tested in this trial
Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active
DeviceThe study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula, a core salience network node.
Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham
DeviceThe study will utilize an identical protocol using the H4 coil to administer a sham condition.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active dTMSExperimental treatment 1 intervention
Group B: Sham dTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insula Function
The primary measure of SN function will include insula activation during the monetary incentive delay task, anticipation of loss contrasted with no loss
Time frame
1-4 days post-treatment2
Percentage of Days Abstinent
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
Time frame
3 months post-treatmentSecondary outcomes
1
Other Salience Network Function
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.
Time frame
1-4 days post-treatment2
Resting-State Salience Network
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.
Time frame
1-4 days post-treatment3
Binary Relapse
Binary (yes/no) relapse after treatment via self-report
Time frame
3 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
VA Palo Alto Health Care System
Collaborator
Source ClinicalTrials.gov