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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The surgical or medical risk for the patient is too high if they undergo the investigational procedure.You have a history of bone disorders that may affect the safety and effectiveness of using the device or getting a device implant.You have had a brain injury in the past that has affected your thinking abilities.You might need to undergo a complete body MRI scan during the study.You have been diagnosed with long-term or repeated depression, and are currently going through a severe episode of depression.You have a baseline score of 20 or higher on a test that measures your level of depression symptoms.You have a history of severe mental disorders like schizophrenia or schizoaffective disorder, or you are currently experiencing a major depressive episode with psychotic features.You have a brain condition like epilepsy, dementia, or problems with memory and thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention, Placement of Device & Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.