RECRUITING

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

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Conditions

Stimulant Use DisorderTMSMRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

Quick Facts

Study Start:2024-12-01
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06790576

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * Ability to provide consent and comply with all study procedures.
  3. * 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).
  4. * At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
  5. * Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
  6. * Confident level of English language proficiency.
  1. * Any organic brain disorder (e.g. TBI, stroke).
  2. * Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
  3. * TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
  4. * 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).
  5. * Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
  6. * Presence of a condition that would render study measures impossible to administer or interpret.
  7. * Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.
  8. * Greater than 9 months abstinence from substance use (does not apply to healthy control participants).
  9. * Pregnancy or breastfeeding.

Contacts and Locations

Study Contact

Melnie Stimac
CONTACT
612-301-2449
stima011@umn.edu

Principal Investigator

Kelvin Lim
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Kelvin Lim, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-12-01
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • TMS
  • MRI

Additional Relevant MeSH Terms

  • Stimulant Use Disorder