tAN for PTSD and OUD in Buprenorphine Therapy

The Sparrow Ascent device from Spark Biomedical (Dallas, TX), applies stimulation frequencies of 15 Hz at the cymba concha (vagal innervation) and 100 Hz anterior to the tragus (trigeminal innervation). Both tAN and active sham conditions have square biphasic waveforms with identical pulse widths of 250 µs separated by a 125 µs interval between pulses. Stimulation is applied using a duty cycle of 5-minutes ON and 10 seconds OFF. The stimulation intensities (mA) will be programmed for each individual based on the highest amplitude for each channel that is both comfortable and perceptible. Patients using the device may alter the intensity of stimulation at these sites using the Patient Controller to achieve the desired effect.

The Sparrow Ascent Active Sham is a modified version of the Sparrow Ascent tAN System that has been designed to provide sub-therapeutic stimulation to the trigeminal nerve only and no stimulation to the vagus nerve. The trigeminal nerve will receive 1 Hz stimulation at the temporomandibular region at an amplitude that is comfortable and perceptual. The pulse duration will be set to a value that does not exceed 250 μs in a square biphasic waveform. The patient controller device for the active sham will give the appearance that stimulation is being applied at both vagal and trigeminal electrode sites.