Epidural Cortical Stimulation for Depression (NCT00565617) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Epidural Cortical Stimulation for Depression
United States5 participantsStarted 2007-10
Plain-language summary
Objective: Chronic epidural cortical stimulation (ECS) involves the neurosurgical placement of an electric wire on the surface of the brain with intermittent activation. Over time, ECS modulates local and distal connected brain regions. It is being currently applied over the motor cortex to treat intractable pain. Because of the important role played by the medial prefrontal cortex in mood regulation, the goal of this study is to apply this minimally invasive neurostimulation modality over medial prefrontal cortex in severely ill depressed subjects who have failed all other attempts at treatment.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion Criteria:
To be eligible for this study, a subject must meet all the following inclusion and exclusion criteria:
* Subject has a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and is currently experiencing a major depressive episode without psychotic features as defined by DSM IV criteria.
* Subjects may have a diagnosis or unipolar or bipolar depressive episode.
* 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.
* Baseline HDRS 24-item ≥ 20 (both visits 1 week apart)
* Subject must be able to complete the evaluations needed for this study including the functional imaging scans.
* Subject must have had a history of one successful course of ECT in the past.
* Subject must provide written informed consent.
* Subject is stable on all antidepressant medication for at least 4 weeks before the baseline visit or not be taking antidepressant medication prior to entering the study.
* Subject must be able to remain on current medication schedule for the first 19 weeks of the study.
* Subject is not on a medication known to increase the risk of cortical stimulation-induced seizures. These include theophylline, stimulant medications, bupropion, or supraphysiological doses of thyroid supplements.
Exclusion Criteria:
The presence of an…