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Neurostimulation Device
Epidural Cortical Stimulation for Depression (EpCS-D Trial)
N/A
Waitlist Available
Led By Edward B Short, MD, MSCR
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has not had an adequate response to 4 or more adequate antidepressant treatments in the current depressive episode according to the Antidepressant Treatment History Form (ATHF) (Sackeim et al 1997)
Subject must be between the ages of 21 and 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months from baseline
Awards & highlights
EpCS-D Trial Summary
This trial is testing whether chronic epidural cortical stimulation (ECS), which involves placing an electric wire on the surface of the brain, can help treat severely depressed patients who have not responded to other treatments.
Who is the study for?
This trial is for adults aged 21-80 with severe depression lasting two years or more, or those who have had multiple episodes. They must have tried and not responded to at least four different antidepressant treatments and can't be on certain medications that increase seizure risk. Participants should be stable on their current meds, able to undergo functional imaging scans, and have previously had a successful course of ECT.Check my eligibility
What is being tested?
The study tests epidural cortical stimulation (ECS), where an electric wire is placed on the brain's surface over the medial prefrontal cortex—a key area in mood regulation. This minimally invasive technique aims to help those with major depressive disorder who haven't improved after trying other treatments.See study design
What are the potential side effects?
While specific side effects are not listed here, ECS may include risks similar to other neurostimulation procedures such as discomfort at the implant site, headache, infection risk from surgery, seizures due to electrical stimulation especially if there's a history of seizures or scarring from previous neurosurgery.
EpCS-D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't improved after 4 or more depression treatments.
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I am between 21 and 80 years old.
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I have been diagnosed with long-term or recurrent depression and am currently experiencing a major depressive episode.
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I am not taking medications that increase seizure risk.
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I have had a successful ECT treatment before.
EpCS-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HDRS-24 Items
EpCS-D Trial Design
1Treatment groups
Experimental Treatment
Group I: Synergy, Epidural cortical stimulationExperimental Treatment1 Intervention
Epidural cortical stimulation (medial prefrontal cortex) for treatment resistant depression. The primary aim of this pilot study was to assess the feasibility and safety of EpCS in patients with treatment-resistant depression. Ultimately, for EpCS to be found effective, a much larger double blind placebo controlled study would be needed.
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Who is running the clinical trial?
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,660 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,385 Total Patients Enrolled
National Alliance for Research on Schizophrenia and DepressionOTHER
96 Previous Clinical Trials
4,124 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on blood thinners or have low platelet counts or bleeding risks.I haven't improved after 4 or more depression treatments.I can stick to my current medication schedule for the first 19 weeks of the study.I have been stable on my antidepressant for over 4 weeks or am not on any.I am between 21 and 80 years old.I am pregnant.I have been diagnosed with long-term or recurrent depression and am currently experiencing a major depressive episode.I have been diagnosed with depression, either unipolar or bipolar.I have not had general anesthesia in the last 30 days, except for ECT.I am not taking medications that increase seizure risk.I have had a successful ECT treatment before.
Research Study Groups:
This trial has the following groups:- Group 1: Synergy, Epidural cortical stimulation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this clinical trial over 65 years old?
"Patients of legal age, aged 21 to 80 years old, are being considered for participation in this medical trial."
Answered by AI
Does this experiment have openings for participants?
"Clinicaltrials.gov indicates that this medical experiment, which was posted in October 2007 and last edited on March 14th 2022 is not recruiting patients at the present moment. However, there are presently 1,297 other trials actively searching for participants."
Answered by AI
Who is eligible to take part in this medical investigation?
"This clinical trial is currently recruiting 5 individuals with a treatment-resistant depressive disorder, aged between 21 and 80. To be considered for the study, candidates must satisfy the following parameters:"
Answered by AI
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