Neurocircuitry of addiction.
George F Koob, Nora D Volkow
https://pubmed.ncbi.nlm.nih.gov/19710631Actively Recruiting
Phase Not Applicable
Age: 25Years - 75Years
All Genders
ID06578429
Deep TMS Neuromodulation of Neural Circuits Associated With Stimulant Use Disorder
Led by Stanford University · Updated on 2025-09-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
V
VA Palo Alto Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of deep transcranial magnetic stimulation (dTMS) as a potential treatment for Veterans with moderate to severe methamphetamine use disorder (MUD). This study investigates a novel approach using H4 coils designed to target deeper and broader brain areas, including the bilateral insula, which is part of the brain's salience network associated with addiction and relapse risk. The goal is to better understand how this innovative brain stimulation may influence brain function and treatment outcomes for MUD. Participants will be randomly assigned to receive either active dTMS or sham dTMS using the H4 coil. Treatments consist of 30 sessions administered three times daily over 10 consecutive business days, with each session lasting about 30 minutes. The active coil aims to modulate key brain circuits involved in addiction, while the sham coil provides a comparison to evaluate the true effects of the stimulation. During the study, participants will undergo assessments shortly after treatment to evaluate insula function and other salience network activity. Researchers will also track the percentage of days participants remain abstinent and whether relapse occurs over a three-month period following treatment. The study includes careful monitoring to ensure participants' safety and adherence, with a total participation timeline extending at least three months after treatment.
CONDITIONS
Brief Title
Deep TMS of Neural Circuits Associated With Stimulant Use Disorder
Who Can Participate
Age: 25Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Must be within the age range of 25 to 75 years
- Meet DSM-5 criteria for moderate to severe methamphetamine use disorder (4 or more diagnostic symptoms)
- Able to obtain a Motor Threshold during screening
- Have a stable condition and environment to attend scheduled clinic visits
- Able to read, understand, verbalize, and sign informed consent in English
- If on medication for comorbid symptoms, medication regimen must be stable throughout the study
- Must be fluent in English
You will not qualify if you...
- Contraindications to TMS or MRI such as cardiac pacemaker, cochlear implant, deep brain stimulation device, ferromagnetic metal near treatment area, claustrophobia, pregnancy or breastfeeding
- Medical, neurological, or general conditions interfering with participation or assessments
- Unable to safely stop medications increasing seizure risk at least two weeks before treatment
- Current substance abuse confirmed by positive toxicology
- Presence of mass lesion, cerebral infarct, seizure disorder, or active CNS disease
- Recent suicide attempt within 30 days or current suicidal plan; requires safety plan
- Severe vision, hearing, or hand movement impairment
- History of moderate or severe traumatic brain injury (loss of consciousness over 10 minutes)
- Use of benzodiazepines, neuroleptic medications, or drugs altering seizure threshold
- Acute or unstable chronic illness
- Current or lifetime bipolar disorder or psychosis
- Participation in another intervention-based clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 consecutive business days
Participants receive 30 active or sham Deep Transcranial Magnetic Stimulation (dTMS) sessions targeting the bilateral insula, administered 3 times per day over 10 consecutive business days. Each treatment visit lasts approximately 30 minutes.
30 treatment visits (in-person)
Follow-up
Duration - Up to 3 months post-treatment
Participants are monitored for treatment outcomes and relapse risk up to 3 months after completing treatment.
Visits at 1 to 4 days and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Actively Recruiting
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Research Team
S
Samantha Ward, BS
E
Eileen G Fischer, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35160085