Intervention, Placement of Device & Stimulation for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University in St Louis School of Medicine, Saint Louis, MO
Depression+3 More
INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 our 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. We anticipate 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. We 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.

Eligible Conditions

  • Depression
  • Severe Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 months

12 months
Decrease in depression symptoms
Increase in cognitive function

Trial Safety

Trial Design

1 Treatment Group

Intervention, Placement of Device & Stimulation
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Intervention, Placement of Device & Stimulation · No Placebo Group · N/A

Intervention, Placement of Device & Stimulation
Device
Experimental Group · 1 Intervention: INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Washington University in St Louis School of Medicine · Saint Louis, MO
Photo of Saint Louis  1Photo of Saint Louis  2Photo of Saint Louis  3
2017First Recorded Clinical Trial
1 TrialsResearching Depression
8 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to provide written informed consent and have signed the consent form for participation in this study.
You have a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and are currently experiencing a major depressive episode as defined by DSM V criteria.
You have a pre-treatment score of >/=20 on the MADRS.
Subject has not had an adequate 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 Treatment History Form (ATHF) (Gaynes, 2020).
The subject has completed all baseline testing to determine eligibility for the implant surgery.
You are female and not pregnant, agree to use adequate birth control, or are not capable of becoming pregnant (e.g.
You have a subject age between 21 and 80.\n
Subjects must be able to complete the evaluations needed for this study including the high resolution CT and MRI brain imaging scans.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.