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PCS in Severe Treatment Resistant Depression
NCT04124341 · University of Minnesota
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression
About this study
This study has five 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.
Stage 4: 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.
Stage 5: Long Term Follow up (4 years) All participants who complete stage 4 will be offered continued treatment. Participants complete follow up visits every three months, alternating between in person and over zoom. Assessments of symptoms are made. Pregnancy tests will be done as appropriate.
Objectives To demonstrate that PCS causes meaningful and sustained antidepressant response.
To demonstrate that precision functional mapping can identify individualized depression patterns which will lead to personalized maps for targeting the stimulation for an individual.
To establish safe parameters for PCS that do not generate after discharge seizures.
Eligibility criteria
Inclusion Criteria:
* Participant must be able to provide written informed consent.
* Participant has a diagnosis of chronic (greater than or equal to 2 years) depressive episode as defined by DSM V criteria
* Participant has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the Antidepressant Treatment History Form (ATHF)
* Participant must have had ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them
* Participant must have HRSD greater than or equal to 20 at study entry
* Participant must be able to complete the evaluations needed for this study including the functional imaging scans and the EEG Bayesian optimization sessions
* Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and inform study team of any change to care team during study participation
* Participant must agree to allow all forms of communication between investigators and study staff and any health care provider (current or having provided service within two years of enrollment)
* Participant must provide name and contact information for at least two people greater than or equal to 22 in age who reside within a 30 minute drive of the participant's residents and whom staff may contact as necessary during study participation
* Participant must be enrolled in a Medicare program
Exclusion Criteria:
* The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
* Participant is unable to undergo required full body magnetic resonance imaging (MRI) during the clinical study
* Participant is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the PCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide or scores 21 or higher on the MSSI)
* In addition to the acute suicidal risks mentioned above, participant meets any of the following:
1. Has made a suicide attempt within the previous 12 months that required medical treatment
2. Has made greater than or equal to two suicide attempts in the past 12 months
3. Has a clear-cut plan for suicide that states that she/he cannot guarantee that she/he will call her/his regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study
4. Is likely to attempt suicide within the next six months, in the Investigator's opinion
* Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria
* Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23
* Participant with a positive urine pregnancy test
* Participant with a positive urine drug screen
* Participant with DBS (Deep Brain Stimulator)
* Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment
* Participant with history of seizures
* Participant determined by surgical safety committee to have cerebral atrophy, neurodegenerative or neurovascular disease due to age or medical condition that would prohibit optimal surgical safety, per clinical MRI
Study design
Enrollment target: 15 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-09-29
Estimated completion: 2032-12-31
Last updated: 2026-01-20
Interventions
Device: Prefrontal Cortical Stimulation (PCS)
Primary outcomes
- • Change in HRSD Scores (12 months)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactZiad Nahas, MD, MSCR · contact · znahas@umn.edu · 952-525-4505
ContactRachel Johnson, PhD · contact · ipl@umn.edu · 952-525-4505
InvestigatorZiad Nahas, MD · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States