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Behavioural Intervention

Transcranial Electrical Stimulation for mTBI (TESmTBI Trial)

N/A
Waitlist Available
Led By Mingxiong Huang, PhD
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks

Summary

This trial is testing IASIS and Nexalin treatments, which use gentle electrical pulses on the head, to help Veterans with mild traumatic brain injury (mTBI) who have ongoing symptoms. The goal is to see if these treatments can help the brain repair itself by promoting changes in brain activity. IASIS is a passive neurofeedback-based treatment that uses low-intensity pulses for mTBI.

Eligible Conditions
  • PTSD
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Abnormal Magnetoencephalography (MEG) Slow-Waves (1-4 Hz) Activity
Neurobehavioral Symptoms Inventory
Rivermead Post Concussion Symptom Questionnaire
Secondary study objectives
Barratt Impulsivity Scale
California Verbal Learning Test-2nd Edition - Free Recall Total Correct T-score
Clinician-Administered PTSD Scale (CAPS-5)
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Transcranial Electrical Stimulation (TES)Experimental Treatment1 Intervention
mTBI Veterans blindly assigned to a 6 week of TES, either IASIS neurofeedback treatment or Nexalin, with 2-3 sessions per week.
Group II: ControlActive Control1 Intervention
Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Group III: Sham TreatmentPlacebo Group1 Intervention
mTBI Veterans blindly assigned to a sham treatment for 6 weeks with 2-3 sessions per week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TES
2017
N/A
~70

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,605 Total Patients Enrolled
San Diego Veterans Healthcare SystemFED
37 Previous Clinical Trials
5,399 Total Patients Enrolled
Mingxiong Huang, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
~7 spots leftby Dec 2025
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