acTBS Treatment for Inpatient Subjects With Suicidality

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

January 1, 2029

Study Completion Date

January 1, 2029

Conditions
Suicidality
Interventions
DEVICE

accelerated Thetaburst stimulation

"We will administer 20-30 treatment sessions over the course of the study. The study technician will place the coil over the Fp2 electrode of a 10-20 International EEG system hair net, to approximate stimulation of the R-OFC). For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT.~Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays. We estimate all study-related treatments will be complete in 5-6 weekdays."

DEVICE

Sham Comparator

All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.

Trial Locations (1)

90025

Resnick Neuropsychiatric Hospital, Los Angeles

All Listed Sponsors
lead

University of California, Los Angeles

OTHER

NCT04197765 - acTBS Treatment for Inpatient Subjects With Suicidality | Biotech Hunter | Biotech Hunter