Intracalvarial Prefrontal Cortical Stimulation in Treatment-Resistant Depression
Inner Cosmos Inc
Summary
Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose. In the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline. The investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: To be eligible for this study, a subject must meet all the following inclusion: 1. Subject has a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and is currently experiencing a major depressive episode as defined by DSM V criteria. 2. Subject meets a pre-treatment baseline threshold with MADRS score of \>/=20 3. Subject has not had an sustained response to two or more adequately dosed antidepressant treatments from at least two different antidepressant treatment classes in the current depressive episode according to the Antidepressant…
Interventions
- DeviceINTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION
Subjects will have the neurostimulation device placed in the skull and continuous stimulation will be applied to relieve symptoms of depression.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Washington University in St Louis School of MedicineSt Louis, Missouri