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Behavioural Intervention
Transcranial Electrical Stimulation (TES) for PTSD (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
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 moreTrial 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
1,658 Previous Clinical Trials
3,361,582 Total Patients Enrolled
San Diego Veterans Healthcare SystemFED
37 Previous Clinical Trials
5,549 Total Patients Enrolled
Mingxiong Huang, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
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