What side effects are associated with this type of intervention?

Common treatments for depression that involve neuromodulation, such as Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), and Deep Brain Stimulation (DBS), have various side effects. TMS can cause headaches, scalp discomfort, and, rarely, seizures. tDCS may lead to mild tingling, itching, or redness at the site of stimulation. DBS, being more invasive, carries risks of infection, hemorrhage, confusion, and seizures, with hardware malfunctions also being a concern. These side effects are generally manageable and reversible, but the invasive nature of some treatments like DBS necessitates careful consideration.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of depression, particularly for treatment-resistant cases. Transcranial Magnetic Stimulation (TMS) is a non-invasive procedure that stimulates the dorsolateral prefrontal cortex and has been approved for major depressive disorder. Vagus Nerve Stimulation (VNS) is another FDA-approved treatment for chronic or recurrent depression that has not responded to at least four antidepressant treatments. Additionally, various pharmacological treatments, including selective serotonin reuptake inhibitors (SSRIs) and atypical antipsychotics, have been approved for depression management.

What other types of research exist?

Promising, novel alternatives to Intracalvarial Prefrontal Cortical Stimulation for depression include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown efficacy in reducing migraine pain and may have potential for depression treatment. 2) Remote Electrical Neuromodulation, which involves nonpainful electrical skin stimulation and has shown positive results in migraine trials. 3) Transcranial Magnetic Stimulation (TMS), particularly single-pulse TMS, which has shown effectiveness in reducing headache days and functional disability in migraine patients and may be applicable to depression treatment.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention, Placement of Device & StimulationExperimental Treatment1 Intervention

Placement of neurostimulation device \& stimulation of prefrontal cortex target

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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

1,970 Previous Clinical Trials

2,308,603 Total Patients Enrolled

67 Trials studying Depression

10,836 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

~7 spots leftby Dec 2025

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