Transcranial Electrical Stimulation for mTBI

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Mild Traumatic Brain Injury (mTBI)Post-traumatic Stress Disorder
Interventions
DEVICE

TES

"The EEG interface device is the J\&J Engineering I-330 C2. IASIS is delivered via the 4 EEG leads with respect to the Common Neck Reference. During each session, 2 electrodes are attached to the participant's left and right mastoids, while the remaining 2 electrodes are moved to various locations on the scalp to record EEG signals. All 4 electrodes are involved in applying weak electric current pulses back to the brain. The feedback signal consists 2 types of narrow pulse trains, both with 150mV in amplitude.~The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a waveform that provides tES to the brain delivered at a frequency of 4Hz, 40Hz, and 77.5Hz at 0 to 15mA peak current. Evidence shows this waveform, at these frequencies, results in improved clinical outcomes for anxiety and pain. We hypothesize that repeated TES treatments serve to stimulate long-term neurochemical changes."

Trial Locations (1)

92161

VA San Diego Healthcare System, San Diego, CA, San Diego

All Listed Sponsors
collaborator

San Diego Veterans Healthcare System

FED

lead

VA Office of Research and Development

FED

NCT03244475 - Transcranial Electrical Stimulation for mTBI | Biotech Hunter | Biotech Hunter