Responsive Neurostimulation for Post-Traumatic Stress Disorder

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 22, 2021

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Post-Traumatic Stress Disorder
Interventions
DEVICE

NeuroPace® RNS® System

In this intervention, patients suffering from PTSD undergo a surgical procedure to implant the responsive neurostimulation device (RNS, NeuroPace). This procedure involves the placement of a depth lead bilaterally in the amygdala and hippocampus following a trans-occipital trajectory. The two leads are then connected to a pulse generator fixated to the skull. RNS is able to detect specific signals from the target and to respond with a programmed electrical stimulation. One month after the implantation of the system, the patients will undergo 3 tasks: a fear conditioning task, the international affective picture system and the subsequent memory recall paradigm. These tasks will yield electrophysiological biomarkers of arousal and re-experiencing. We will then program RNS to detect and respond to those biomarkers. The patients will be followed longitudinally for improvement and evidence of target engagement as seen on cerebral metabolism and global electroencephalography.

Trial Locations (1)

90073

RECRUITING

VA Greater Los Angeles, Los Angeles

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

lead

VA Greater Los Angeles Healthcare System

FED