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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

Must not have

Subject on anticoagulant drugs, with low platelets counts or have PT or PTT abnormalities or other risk factors for intra-operative or post-operative bleeding

Female subjects with a positive urine pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months from baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on blood thinners or have low platelet counts or bleeding risks.

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I am pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HDRS-24 Items

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: 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.

0 / 7Eligibility criteria met