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Device

rTMS for Stimulant Addiction (VA-StARTS Trial)

N/A
Recruiting
Led By Jong H. Yoon, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SCID confirmed diagnosis of SUD, severe
IQ > 80
Must not have
On medications thought to significantly lower seizure threshold: clozapine, chlorpromazine, clomipramine, bupropion > 400 mg/day, Use of direct dopaminergic antagonists or agonists
History of seizures or conditions known to substantially increase risk for seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week before and after rtms treatment
Awards & highlights

Summary

This trial will test a new treatment, repetitive transcranial stimulation (rTMS), for Veterans with stimulant use disorder (SUD). The goal is to see if rTMS is effective and to identify biomarkers that may help predict who will respond best to treatment.

Who is the study for?
This trial is for Veterans with severe stimulant use disorder (SUD) who have not used stimulants for 1-6 weeks. Participants must be able to undergo cognitive tests, fMRI scans, and rTMS treatment without contraindications, have an IQ over 80, a stable medication regimen and living situation. Exclusions include incompatible implants or devices, unstable medical/psychiatric conditions, other active substance disorders (except PTSD), pregnancy/lactation, prior adverse reaction to TMS or medications lowering seizure threshold.Check my eligibility
What is being tested?
The study is testing repetitive transcranial magnetic stimulation (rTMS) as a potential new treatment for SUD in Veterans. It aims to establish the feasibility of rTMS application in this population and evaluate its effectiveness while identifying biomarkers that could predict which patients will benefit most from this therapy.See study design
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The risk of seizures is higher if participants are on certain medications or have specific medical conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a severe substance use disorder diagnosis.
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My IQ is above 80.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on high-risk seizure medications like clozapine or bupropion over 400 mg/day.
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I have a history of seizures or conditions that raise my seizure risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week before rtms treatment, midpoint during rtms treatment, within 1 week after rtms treatment, and 3 months following rtms treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 week before rtms treatment, midpoint during rtms treatment, within 1 week after rtms treatment, and 3 months following rtms treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse rate
Secondary outcome measures
Occupational/role functioning
Rest/activity cycles
Reward circuit function and signaling

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
Receive active rTMS
Group II: Sham rTMSPlacebo Group1 Intervention
Receive sham rTMS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive transcranial magnetic stimulation (rTMS)
2017
Completed Phase 4
~700

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment for Stimulant Use Disorder (SUD) that uses magnetic fields to modulate neural activity in specific brain regions, particularly the prefrontal cortex. This area is involved in addiction and reward pathways, and rTMS aims to reduce cravings and improve self-control by altering neural circuits. This mechanism is significant for SUD patients as it provides a treatment option that directly influences brain function without relying on medications, which can have side effects or potential for misuse.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,931 Total Patients Enrolled
Stanford UniversityOTHER
2,411 Previous Clinical Trials
17,462,891 Total Patients Enrolled
Jong H. Yoon, MDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Repetitive transcranial magnetic stimulation (rTMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04228276 — N/A
Stimulant Use Disorder Research Study Groups: Sham rTMS, Active rTMS
Stimulant Use Disorder Clinical Trial 2023: Repetitive transcranial magnetic stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT04228276 — N/A
Repetitive transcranial magnetic stimulation (rTMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228276 — N/A
~11 spots leftby Jul 2025