PCS in Severe Treatment Resistant Depression
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|ClinicalTrials.gov Identifier: NCT04124341|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : September 21, 2022
This research study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. Participants receive intermittent electrical stimulation to the brain, which involves surgically placing electric leads in between the tough fibrous membrane covering the surface of the brain and the surface of the brain itself. This type of stimulation is referred to as bilateral subdural prefrontal cortical stimulation (PCS) because it will specifically target the outer layer of the brain at the midline, right behind the forehead. It uses a pacemaker-like device, the Proclaim Elite SCS System (Abbott Laboratories) for stimulation.
Although the U.S. Food and Drug Administration (FDA) has approved the system for brain stimulation for patients with chronic pain and muscular diseases, such as Parkinson's, its use is still investigational, and the surgery is still experimental for patients who have depression.
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Device: Prefrontal Cortical Stimulation (PCS)||Not Applicable|
This study has four distinct stages.
Stage 1: Baseline Assessments There is a 14-day baseline period to determine eligibility, including medical history, physical and neurological examinations, and medical test including EKG, blood work, pregnancy test, depression assessments and cognitive assessments. An MRI will also be done prior to implant in order to help the surgeon determine where best to place the leads.
Stage 2: Surgery If deemed to be medically eligible, participants will be hospitalized for a minimum of 3 days, during which they will undergo surgery to implant the device and leads. There will be testing of the leads to explore optimal testing parameters. According to the surgeon's judgment, participants may or may not receive stimulation for 3 weeks following surgery.
Stage 3: Acute phase (19 weeks) Following implantation, participants undergo a CT scan to ensure proper implantation. Later, participants complete 10 follow up visits where assessments of symptoms will be made. Additionally, the first visit will consist of the investigator programming the stimulator while participants watch various photographs with different emotional content and have their brain electrical activity recorded. This will help the investigator choose the best settings for treatment. Pregnancy tests will be done as appropriate, and blood will be drawn at two visits.
Stage 4: Long term follow up (7 months) All participants who complete stage 3 will be offered continued treatment. Participants complete 7 monthly follow-up visits where assessments of symptoms are made. Pregnancy tests will be done as appropriate, and blood will be drawn at each visit.
Objectives (confirm target engagement and demonstrate clinical relevance):
To assess the impact of PCS on Late Positive Potential (LPP), which reliably captures biased attention and early affective responses to environmental stimuli.
To examine the relationship between changes in LPP and clinical improvement.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression|
|Actual Study Start Date :||September 29, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Prefrontal Cortical Stimulation (PCS)
Stereotactically implanted bilateral PCS
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.
- Change in LPP Amplitude [ Time Frame: 6 months ]Change in late positive potential (LPP) amplitude as a result of Bayesian optimized bilateral PCS. LPP is an event-related potential (ERP) measured by electroencephalography (EEG), which reliably captures biased attention and early affective responses to environmental stimuli.
- Change in HRSD Scores [ Time Frame: 6 months ]In order to demonstrate that sustained lowering of LPP as a result of Bayesian optimized bilateral PCS, impacts depressive symptoms, change in Hamilton Rating Scale for Depression (HRSD) scores will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124341
|Contact: Ziad Nahas, MD, MSCRfirstname.lastname@example.org|
|Contact: Rachel Johnsonemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Ziad Nahas, MD, MSCR|
|Principal Investigator:||Ziad Nahas, MD||University of Minnesota|