Recruiting
Phase 1

Transcranial Magnetic Stimulation

Sponsor:

University of Minnesota

Code:

NCT06790576

Conditions

Stimulant Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

closed-loop-peak

Open-loop

closed-loop-trough

Study Details

Brief summary:

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

Stimulant Use Disorder

Study ID

NCT06790576

Start date

Dec 1, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants assigned to closed-loop-peak

experimental: Group 2

Participants assigned to open-loop

experimental: Group 3

Participants assigned to closed-loop-trough

Interventions

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)

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)

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)

Primary outcome measure

  • TEP individual response [ Time Frame: 2 hours ]
  • Cognitive response [ Time Frame: Measured immediately after the iTBS ]

Central Contacts and Locations

Central contacts

Melnie Martie

612-301-2449stima011@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Melanie Martie

612-301-2449stima011@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • TMS
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-01.