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NCT06790576 · ClinicalTrials.gov registry record · Phase 1
Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
A Phase 1 study of Stimulant Use Disorder, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06790576 is a Phase 1 study of Stimulant Use Disorder that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 50 participants, below the 205-participant average among 9 other Stimulant Use Disorder trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06790576, a Phase 1 study of Stimulant Use Disorder, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER closed-loop-peak
- OTHER Open-loop
- OTHER closed-loop-trough
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06790576
The ClinicalTrials.gov registry entry for NCT06790576 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 9 other Stimulant Use Disorder trials with a reported enrollment target (76% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stimulant Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which closed-loop-peak is the first listed.
NCT06790576 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06790576 about?
NCT06790576 is a clinical study titled "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 ...
What is the current status of trial NCT06790576?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-12-01. Estimated completion is 2026-12-01.
What conditions does trial NCT06790576 study?
This clinical trial studies the following conditions: Stimulant Use Disorder.
What interventions are being tested in trial NCT06790576?
The interventions under investigation include: closed-loop-peak (OTHER), Open-loop (OTHER), closed-loop-trough (OTHER).
Who is sponsoring clinical trial NCT06790576?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06790576 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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