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NCT Number: NCT06790576

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

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.

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Key information

Conditions

Stimulant Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Melanie Martie

CONTACT

[email protected]

612-301-2449

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Ability to provide consent and comply with all study procedures.
  • Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).
  • At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
  • Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
  • Confident level of English language proficiency.

Exclusion criteria

  • Any organic brain disorder (e.g. TBI, stroke).
  • Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
  • TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
  • MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).
  • Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
  • Presence of a condition that would render study measures impossible to administer or interpret.
  • Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.
  • Greater than 9 months abstinence from substance use (does not apply to healthy control participants).
  • Pregnancy or breastfeeding.

Treatment and study plan

closed-loop-peak

Other

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-peak (each pulse synchronized to person's peak of theta waveform)

Open-loop

Other

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: open-loop (TMS pulse delivered without regard to EEG)

closed-loop-trough

Other

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-trough (each pulse synchronized to trough of theta waveform)

Primary outcomes

  1. TEP individual response

    Time frame: 2 hours

    Use TMS-evoked potentials (TEPs) to assess individual response to three TMS-EEG synchronization methods: random, peak, and trough.

  2. Cognitive response

    Time frame: Measured immediately after the iTBS

    Investigate the CSST task cognitive response to three TMS-EEG synchronization approaches during intermittent Theta Burst Stimulation (iTBS).

Study contacts

Contact information is provided by the study sponsor or research team.

Melnie Martie

CONTACT

[email protected]

612-301-2449

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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