RecruitingNot ApplicableNCT06578429

Deep TMS of Neural Circuits Associated With Stimulant Use Disorder

Deep TMS Neuromodulation of Neural Circuits Associated With Stimulant Use Disorder


Sponsor

Stanford University

Enrollment

30 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 25 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria12

  • 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.

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Interventions

DEVICEDeep 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.

DEVICEDeep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham

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


Locations(1)

VA Palo Alto Health Care System

Palo Alto, California, United States

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NCT06578429


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