Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

February 5, 2026 updated by: University of Minnesota

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants assigned to closed-loop-peak
Other: closed-loop-peak
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)
Experimental: Group 2
Participants assigned to open-loop
Other: Open-loop
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)
Experimental: Group 3
Participants assigned to closed-loop-trough
Other: closed-loop-trough
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
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).
Measured immediately after the iTBS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Kelvin Lim, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSYCH-2024-32713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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