Deep TMS of Neural Circuits Associated With Stimulant Use Disorder

Launched by STANFORD UNIVERSITY · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called deep transcranial magnetic stimulation (dTMS) for Veterans who have a methamphetamine use disorder (MUD). The goal is to see if this treatment can help individuals struggling with problems related to methamphetamine use. If you or someone you know is between the ages of 25 and 75 and has been diagnosed with moderate to severe MUD, they might be eligible to participate in this study. Participants need to be stable in their condition and able to attend scheduled clinic visits, and they must be able to read and sign consent forms in English.

If someone joins the trial, they can expect to receive dTMS treatment while attending regular appointments. However, there are certain health conditions that could prevent someone from participating, such as having a heart device, certain neurological disorders, or severe vision or hearing issues. It's important for potential participants to discuss their medical history with the study team to determine if they qualify. This trial is currently recruiting, so interested individuals can reach out for more information on how to get involved.

Gender

ALL

Eligibility criteria

• 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.