PCS in Severe Treatment Resistant Depression

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    15
  • sponsor
    University of Minnesota
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Updated on 17 September 2023
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Summary

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.

Description

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.

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.

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.

Details
Condition Treatment Resistant Depression
Treatment Epidural Prefrontal Cortical Stimulation (EpCS), Prefrontal Cortical Stimulation (PCS)
Clinical Study IdentifierNCT04124341
SponsorUniversity of Minnesota
Last Modified on17 September 2023

Eligibility

 Yes No Not Sure

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 three 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
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

In addition to the acute suicidal risks mentioned above, participant meets any of the
following
The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
Has made a suicide attempt within the previous 12 months that required medical treatment
Participant is unable to undergo required full body magnetic resonance imaging (MRI) during the clinical study
Has made greater than or equal to two suicide attempts in the past 12 months
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
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)
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
Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23
psychotic features (commonly referred to as psychotic depression) according to
the DSM V criteria
Participant with a positive urine drug screen
Participant with a positive urine pregnancy test
Participant with DBS (Deep Brain Stimulator)
Participant with history of seizures
Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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