Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT06790576

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

Led by University of Minnesota · Updated on 2026-02-09

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits. Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network. Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants. Step 3: Following randomization, the study will administer a pre-iTBS assessment. Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group. Step 5: The study will administer a post-iTBS assessment.

CONDITIONS

Official Title

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Ability to provide consent and comply with all study procedures
  • Diagnosed with stimulant use disorder according to DSM criteria (assessed by MINI and self-report)
  • At least 2 weeks abstinent from substance use except caffeine or nicotine
  • Intend to remain in addiction treatment until the study intervention is completed
  • Confident proficiency in English
Not Eligible

You will not qualify if you...

  • Any organic brain disorder such as traumatic brain injury or stroke
  • Head injury causing skull fracture or loss of consciousness over 30 minutes
  • Contraindications for TMS including history of seizures or metallic cranial implants
  • Contraindications for MRI such as unapproved metallic implants, pacemakers, shrapnel, non-removable piercings, pregnancy, breathing or movement disorders, or claustrophobia
  • Any psychotic disorder (other stable psychiatric disorders allowed)
  • Conditions preventing study measures from being administered or interpreted
  • Primary substance use disorder other than stimulants or cocaine (except caffeine or nicotine)
  • More than 9 months abstinent from substance use (does not apply to healthy controls)
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

M

Melnie Martie

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder | DecenTrialz