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Neuromodulation

Neuromodulation + Cognitive Training for Substance Use Disorders

N/A
Recruiting
Led By Kelvin Lim, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Age outside the range of 18 to 65
A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing a new intervention to help people with substance use disorder by targeting brain biomarkers that make relapse more likely.

Who is the study for?
This trial is for individuals aged 18-65 with substance use disorders (SUD) or alcohol use disorder (AUD), who have been abstinent for at least 3 weeks but not more than 9 months. Participants must intend to stay in their treatment program and meet specific diagnostic criteria, excluding those with neurological conditions, severe head injuries, recent neuromodulation treatments, or under court-mandated rehab.
What is being tested?
The study tests tDCS-Augmented Cognitive Training aimed at improving cognition and treatment outcomes for SUD/AUD. It targets brain biomarkers associated with relapse vulnerability by combining transcranial direct current stimulation (tDCS) with cognitive exercises.
What are the potential side effects?
Potential side effects of tDCS may include mild discomfort or itching under the electrode during application, headache, fatigue, nausea, and insomnia. Cognitive training typically does not cause side effects but can sometimes lead to mental fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 or older than 65.
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I have had a head injury that made me unconscious for more than 30 minutes.
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I have a health condition or have received treatment that affected my nervous system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment2 Interventions
Group II: Sham tDCSPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~630
Cognitive Training
2008
Completed Phase 3
~4100

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,878 Total Patients Enrolled
9 Trials studying Alcoholism
2,045 Patients Enrolled for Alcoholism
Kelvin Lim, MDPrincipal InvestigatorUniversity of Minnesota
4 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

tDCS-Augmented Cognitive Training (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04426214 — N/A
Alcoholism Research Study Groups: Sham tDCS, Active tDCS
Alcoholism Clinical Trial 2023: tDCS-Augmented Cognitive Training Highlights & Side Effects. Trial Name: NCT04426214 — N/A
tDCS-Augmented Cognitive Training (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04426214 — N/A
~13 spots leftby Sep 2025
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