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Behavioral Intervention

Non-Invasive Brain Stimulation for Traumatic Brain Injury (SMART Trial)

Phase < 1
Waitlist Available
Led By David Darrow, 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
Healthy subject exclusion criteria: Less than 18 years of age, open wound on scalp, TBI diagnosis, non-English speaking, incarcerated, implanted defibrillator or pacemaker, visual impairment that hinders ability to complete computerized assessments
Open wound on scalp
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years

Summary

This trial will use electrical stimulation to try and improve cognitive function and decision-making in people who have had a traumatic brain injury.

Who is the study for?
This trial is for adults over 18 who've had a mild to moderate traumatic brain injury (TBI) and can perform computerized tests. They must understand the consent process and commit to all appointments. It's not for those with severe TBI, scalp wounds, pacemakers/defibrillators, non-English speakers, or visual issues affecting computer use.
What is being tested?
The study is testing two types of external non-invasive brain stimulation: transcutaneous alternating current stimulation (TACS) and vagal nerve stimulation (tnVNS), aiming to improve cognitive function and decision-making after a TBI.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, skin irritation from electrode placement, dizziness or nausea during treatment. These are usually mild.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am over 18, speak English, not incarcerated, have no scalp wounds, no TBI, no pacemaker or defibrillator, and can see well enough for computer tasks.
Select...
I have an open wound on my scalp.
Select...
I was diagnosed with a severe brain injury or had a very low consciousness level when admitted.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control2 Interventions
Stimulation
Group II: ShamPlacebo Group1 Intervention
No stimulation

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,428 Previous Clinical Trials
1,620,644 Total Patients Enrolled
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
195 Total Patients Enrolled

Media Library

COGED (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05327829 — Phase < 1
Traumatic Brain Injury Research Study Groups: Sham, Stimulation
Traumatic Brain Injury Clinical Trial 2023: COGED Highlights & Side Effects. Trial Name: NCT05327829 — Phase < 1
COGED (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327829 — Phase < 1
~20 spots leftby Jan 2028
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