Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05393622
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-05-23
Brief Title:
Brain Stimulation for Severe Depression
Sponsor:
Inner Cosmos Inc
Organization:
Inner Cosmos Inc
Study Overview
Official Title:
Intracalvarial Prefrontal Cortical Stimulation in Treatment-Resistant Depression
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 investigators 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
In the investigators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None