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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week before and after rtms treatment
Awards & highlights

VA-StARTS Trial 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.

VA-StARTS Trial Eligibility Criteria

Inclusion Criteria

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

VA-StARTS Trial 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

VA-StARTS 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,236 Total Patients Enrolled
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,341,307 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment permit participants below the age of thirty?

"This clinical trial has a specified age range, where those aged 18 to 65 are eligible for enrollment."

Answered by AI

Is this clinical research currently recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial is currently seeking participants; it was first listed on February 5th 2021 and last updated on February 24th 2022. 48 individuals need to be enrolled from a single location."

Answered by AI

To whom is this medical experiment open for enrollment?

"This study is seeking 48 volunteers, aged between 18 and 65, that have been diagnosed with a stimulants use disorder. Prerequisites for potential participants include: SCID certified SUD diagnosis of severity; abstinence from the usage of stimulants in the past 1 to 6 weeks; an unchanging medication dosages or agents over 2 weeks prior to commencement and throughout treatment phase; secured housing enabling regular visits to medical centres; aptitude for cognitive testing, fMRI scans, and rTMS (no counter-indications); IQ above 80 marks; stable physical health status as well as enrolment at Palo Alto VA's Addiction Treatment Services."

Answered by AI

What is the aggregate patient count for this research experiment?

"Affirmative. Concerning this clinical trial, the information on clinicaltrials.gov attests to its current recruitment status; it was initially posted on February 5th 2021 and most recently updated on February 24th 2022. The study requires 48 individuals at 1 site for enrollment."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
VA Palo Alto Health Care System, Palo Alto, CA
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I saw this and really think it will work for me i believe this can figure out what damage is done too.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. VA Palo Alto Health Care System, Palo Alto, CA: < 24 hours
~0 spots leftby Apr 2024