← Back to Search

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LPP Amplitude
Secondary outcome measures
Change in HRSD Scores

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
1,380 Previous Clinical Trials
1,588,730 Total Patients Enrolled
Ziad Nahas, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

Epidural Prefrontal Cortical Stimulation (EpCS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04124341 — N/A
Major Depressive Disorder Research Study Groups: Prefrontal Cortical Stimulation (PCS)
Major Depressive Disorder Clinical Trial 2023: Epidural Prefrontal Cortical Stimulation (EpCS) Highlights & Side Effects. Trial Name: NCT04124341 — N/A
Epidural Prefrontal Cortical Stimulation (EpCS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04124341 — N/A
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04124341 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do participants of this experiment have to be under a certain age threshold?

"The requirements for this medical trial necessitate that individuals be between 22 and 55 years old."

Answered by AI

What is the upper limit of participants allowed in this medical study?

"Affirmative, the clinicaltrials.gov record demonstrates that this experiment is recruiting participants; it was initially posted on September 29th 2021 and has been revised most recently on September 16th 2022. This investigation requires 15 subjects from one site."

Answered by AI

Are additional participants still being sought for this clinical trial?

"According to clinicaltrials.gov, this trial is open for enrolment and has been since it was initially posted on September 29th 2021. The protocol details were most recently revised on September 16th 2022."

Answered by AI

Am I able to participate in this trial?

"This study is searching for 15 participants aged between 22 and 55 that are suffering from depression. Eligibility criteria include a diagnosis of chronic (2+ years) depressive episode as per DSM V, having undergone ECT or refusing it if clinically indicated, HRSD greater than 20, ability to complete necessary evaluations including EEG Bayesian optimization sessions & functional imaging scans, enrollment in Medicare program, inadequate response to 3+ antidepressant treatments from two different categories according to the ATHF form, care under licensed psychiatrist with regular evaluation updates reported to research team during participation period & consenting for all forms of communication between investigators/study staff and any healthcare"

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Minnesota
How old are they?
65+
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I've tried many medications and nothing has helped me to this day. That's why I'm interested in this study and hopeful I am chosen.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
PCS in Severe Treatment Resistant Depression
2021. "PCS in Severe Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04124341.
~9 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top