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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SMART Trial 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.Check my eligibility
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.See study design
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.
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
SMART Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control2 Interventions
Stimulation
Group II: ShamPlacebo Group1 Intervention
No stimulation
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,479 Total Patients Enrolled
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
195 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I am over 18, had a mild to moderate brain injury, can do computer tasks, and can follow the study plan.I have an open wound on my scalp.I am over 18, can do computer tasks, and can attend all appointments.I was diagnosed with a severe brain injury or had a very low consciousness level when admitted.
Research Study Groups:
This trial has the following groups:- Group 1: Sham
- Group 2: Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still feasible for this experiment?
"According to clinicaltrials.gov, this medical trial is not presently seeking participants. It was first made available on September 15th 2023 and the information was last updated October 15th 2022. Unfortunately, no applicants can be accepted right now; however, 901 other studies are actively recruiting patients currently."
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