Recruiting

Deep TMS

Sponsor:

Stanford University

Code:

NCT06578429

Conditions

Methamphetamine Use Disorder

Transcranial Magnetic Stimulation

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham

Study Details

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).

Conditions

Methamphetamine Use Disorder

Transcranial Magnetic Stimulation

Study ID

NCT06578429

Start date

Mar 15, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion:

  • 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.
  • Participants must be able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English.
  • If participants are on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.
  • Participants must be fluent in English

Exclusion criteria:

  • 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
  • Have a mass lesion, cerebral infarct, or other active CNS disease, including a seizure disorder.
  • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
  • Severe impediment to vision, hearing and/or hand movement, as this is likely to interfere with the ability to follow study protocols.
  • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
  • Taking benzodiazepines or neuroleptic medications, or any medication known to alter seizure threshold.
  • Acute or unstable chronic illness.
  • Current or lifetime history of bipolar disorder or psychosis.
  • Participation in another concurrent intervention-based clinical trial.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active dTMS

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.

sham comparator: Sham dTMS

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.

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active

The 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

The study will utilize an identical protocol using the H4 coil to administer a sham condition.

Primary outcome measure

  • Insula Function [ Time Frame: 1-4 days post-treatment ]
  • Percentage of Days Abstinent [ Time Frame: 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Samantha Ward, BS

650-493-5000samward@stanford.edu

Eileen G Fischer, BS

210-993-2065grace.fischer@stanford.edu

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Eileen Grace Fischer, BS

210-993-2065grace.fischer@stanford.edu

Samantha Ward, BS

650-493-5000samward@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • Veterans
  • Deep Transcranial Magnetic Stimulation (dTMS)
  • Neuroimaging
  • Relapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-09-12.