RecruitingNot applicable

PCS in Severe Treatment Resistant Depression

Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 10 visits
  • Procedures mentioned: Blood draws, Heart tracing (ECG), CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical pulses on the brain’s surface behind the forehead can help severe depression that has not improved with treatment. It is for people with unipolar depression or bipolar I or II depression. The treatment uses wires placed by surgery and a pacemaker-like device, and is experimental for depression.

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 (non-rechargeable) or the Eterna SCS System (rechargeable), both by Abbott Laboratories for stimulation. Although the U.S. Food and Drug Administration (FDA) has approved the Proclaim Elite SCS 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have depression that lasts a long time or keeps coming back, with a score of at least 20 on the HRSD depression rating scale.
  • Have tried at least four antidepressant treatments from at least two treatment groups during the current depression episode without enough improvement.
  • Have had ECT, a treatment that uses electricity to cause a brief seizure, or refused it if recommended.
  • Be able to give written consent and complete study tests, including brain scans and EEG sessions that measure brain activity.
  • Get regular care from a licensed psychiatrist, a doctor who treats mental health conditions, and report any care team changes.
  • Allow study staff to communicate with current health care providers and those who treated you within two years before joining.
  • Give contact details for at least two people age 22 or older who live within a 30-minute drive of your home.
  • For unipolar or bipolar II depression, be enrolled in Medicare. For bipolar I depression, have active health insurance covering standard care and injuries.

Who can't join

  • The study treatment or surgery would be too risky, including because of brain shrinkage or diseases affecting the brain or its blood vessels.
  • Cannot have the required full-body MRI scans.
  • Have a high risk of suicide, including recent plans or actions, an MSSI suicide-risk score of 21 or higher, or a likely attempt within six months. Also excluded: an attempt needing medical treatment or two or more attempts in the past year, or a clear plan without assurance you will call a study doctor or psychiatrist before acting.
  • Have a history of a psychotic disorder, such as schizophrenia, or current depression with symptoms like seeing or hearing things that are not there.
  • Have dementia, which affects memory and thinking, with an MMSE thinking-test score of 23 or lower.
  • Have a positive urine pregnancy test or drug test.
  • Have a deep brain stimulator, or a vagus nerve stimulator that was active within six months before joining. These devices send electrical signals to the brain or a nerve.
  • Have ever had seizures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

If diagnosed with Unipolar or Bipolar Type II treatment resistant depression: Inclusion Criteria: * Participant must be able to provide written informed consent. * Participant has a diagnosis of major depressive episode that is chronic or recurrent as defined by DSM-5 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 If diagnosed with Bipolar Type I treatment resistant depression: Inclusion Criteria: * Participant must be able to provide written informed consent. * Participant has a diagnosis of major depressive episode that is chronic or recurrent as defined by DSM-5 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 an active health insurance plan that will cover the costs associated with standard health care services and injuries 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 sites (1)

MN