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Brain Stimulation
Brain Stimulation for Severe Treatment-Resistant Depression
N/A
Recruiting
Led By Ziad Nahas, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether electrical stimulation of the surface of the brain can help treat depression. participants receive intermittent electrical stimulation to the brain. It is still experimental.
Who is the study for?
This trial is for adults with severe, treatment-resistant depression who have not responded to multiple antidepressant treatments and are under a psychiatrist's care. They must be able to consent, complete necessary evaluations, and have support within a 30-minute drive. Excluded are those with recent suicide attempts or high risk of suicide, active drug use, pregnancy, certain mental health conditions like schizophrenia or psychotic features in their depression.
What is being tested?
The study tests Prefrontal Cortical Stimulation (PCS) using the Proclaim Elite SCS System by Abbott Laboratories. This involves surgical placement of electrical leads on the brain surface behind the forehead to stimulate it intermittently. Although FDA-approved for other conditions like chronic pain and Parkinson's disease, its effectiveness for depression is still being investigated.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, infection risk from surgery, seizures (especially if there's a history), mood changes due to brain stimulation and possible interference with thinking or memory.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in LPP Amplitude
Secondary study objectives
Change in HRSD Scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prefrontal Cortical Stimulation (PCS)Experimental Treatment1 Intervention
Stereotactically implanted bilateral PCS
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,943 Total Patients Enrolled
Ziad Nahas, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a Deep Brain Stimulator implanted.I have not attempted or planned suicide in the last 30 days.I can provide contacts of two people over 22, living within 30 minutes from me, for the study.I am not considered at high risk for suicide in the next six months.I agree to let my doctors and study staff talk about my health.I have had ECT or refused it when it was recommended to me.I have a suicide plan and may not reach out for help if I decide to act on it.I have attempted suicide two or more times in the last year.I have been diagnosed with schizophrenia, schizoaffective disorder, or have had psychotic depression.I have attempted suicide in the past year and needed medical care.I haven't improved after trying three different antidepressants.I am regularly seeing a psychiatrist and will inform the study team of any changes.I have a history of seizures.I have been diagnosed with depression for 2 years or more.I have either undergone ECT or refused it when it was recommended to me.
Research Study Groups:
This trial has the following groups:- Group 1: Prefrontal Cortical Stimulation (PCS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04124341 — N/A