PCS in Severe Treatment Resistant Depression

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 29, 2021

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2032

Conditions
Treatment Resistant Depression
Interventions
DEVICE

Prefrontal Cortical Stimulation (PCS)

Prior to surgery, subjects will undergo a high resolution structural scan to identify anatomical landmarks for rostral anterior and lateral prefrontal cortex. Following identification of target areas, PCS quad leads will be projected over the anterior and lateral prefrontal cortex. Subjects will be kept in the hospital for a minimum of 72 hours for observation during which the investigators will obtain a high resolution spiral CT scan without contrast to confirm lead placements post-operatively and rule out any intra-cranial bleeds. Patients will receive analgesics which they may continue as an outpatient on as needed basis. During this 2-3 weeks recovery period, the attention to pain control and mood is critical. The research team will contact patients at least twice per week to check on their status.

Trial Locations (1)

55455

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER