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Brain Stimulation

Brain Stimulation for Depression

N/A
Recruiting
Led By Jon Willie, MD
Research Sponsored by Inner Cosmos Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new method where an electrode is placed inside the skull to stimulate a brain area involved in mood regulation. It targets patients with severe depression who haven't improved with other treatments. The goal is to see if this method can reduce their depression symptoms. This new treatment option is being scientifically evaluated for patients with major depression who have not responded to conventional treatments.

Who is the study for?
This trial is for adults aged 21-80 with severe depression that hasn't improved after trying at least two different types of antidepressants. They must have had some response to non-invasive neurostimulation, not be pregnant or able to become pregnant, and be capable of undergoing brain scans and cognitive tests.
What is being tested?
The study is testing a minimally invasive brain stimulation technique called IpCS on the prefrontal cortex in patients with treatment-resistant depression. Up to 20 participants will receive an electrode implant and their mood will be monitored over a year using the MADRS scale.
What are the potential side effects?
Potential side effects may include discomfort from the surgical procedure, risk of infection, possible changes in cognition or mood due to stimulation, and any unforeseen reactions related to having an implanted device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in depression symptoms
Secondary study objectives
Change in cognitive function

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: Intervention, Placement of Device & StimulationExperimental Treatment1 Intervention
Placement of neurostimulation device \& stimulation of prefrontal cortex target

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression, particularly neuromodulation techniques like Transcranial Magnetic Stimulation (TMS), Electroconvulsive Therapy (ECT), and Deep Brain Stimulation (DBS), work by targeting and modulating the activity of brain regions involved in mood regulation, such as the dorsolateral prefrontal cortex (DLPFC). These treatments aim to restore normal brain function and alleviate depressive symptoms by altering neural activity patterns. This is particularly important for patients with treatment-resistant depression, as it offers a potential pathway to symptom relief when traditional pharmacotherapy and psychotherapy have failed.
Toward a transdiagnostic neurocircuitry-based biomarker model for pro-cognitive effects: challenges, opportunities, and next steps.Alterations in effective connectivity anchored on the insula in major depressive disorder.

Find a Location

Who is running the clinical trial?

Inner Cosmos IncLead Sponsor
Washington University School of MedicineOTHER
1,997 Previous Clinical Trials
2,298,741 Total Patients Enrolled
68 Trials studying Depression
11,201 Patients Enrolled for Depression
Jon Willie, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05393622 — N/A
Depression Research Study Groups: Intervention, Placement of Device & Stimulation
Depression Clinical Trial 2023: INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) Highlights & Side Effects. Trial Name: NCT05393622 — N/A
INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393622 — N/A
~5 spots leftby Dec 2025