Virtual Reality-Guided TMS for Depression
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications that increase the risk of seizures or have a history of ketamine or MAOI use. If you are on allowed medications like antidepressants or anticonvulsants, your dose must be stable for at least four weeks before the study and remain the same during the study.
What data supports the effectiveness of the treatment Virtual Reality-Guided TMS for Depression?
Research shows that navigated transcranial magnetic stimulation (nTMS) can accurately target specific brain areas, which may improve the effectiveness of repetitive TMS (rTMS) for treating depression. Studies suggest that using a navigation system to guide TMS can lead to more precise targeting of brain regions associated with depression, potentially enhancing treatment outcomes.12345
Is Virtual Reality-Guided TMS for Depression safe for humans?
Transcranial Magnetic Stimulation (TMS), including its navigated forms, has been studied for safety in various conditions, including depression and pre-surgical brain mapping. Studies have shown it to be generally safe and well-tolerated in humans, with no major safety concerns reported in large groups of patients.14678
How is Virtual Reality-Guided TMS for Depression different from other treatments for depression?
Virtual Reality-Guided TMS for Depression is unique because it uses a precise navigation system to target specific brain areas, improving accuracy compared to standard methods. This approach can lead to better clinical outcomes by ensuring the magnetic stimulation is applied to the most effective brain regions for treating depression.12379
What is the purpose of this trial?
This trial tests a new software tool that helps doctors use MRI images to precisely target brain stimulation in patients with depression that doesn't respond to standard treatments. Deep Brain Stimulation (DBS) was originally developed to manage movement disorders like Parkinson's Disease and has shown effectiveness in treating refractory depression.
Eligibility Criteria
This trial is for adults with major depressive disorder who haven't improved after trying at least two depression treatments and TMS using standard methods. They must have moderate to severe depression, not be claustrophobic, free from psychotic disorders or recent substance abuse, not actively suicidal, able to consent, and not pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TMS treatment targeting the L-DLPFC using either virtual or on-line neuro-navigation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Neuro-navigated Transcranial Magnetic Stimulation (TMS)
Neuro-navigated Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Chronic Pain Syndrome
- Treatment-resistant depression
- Obsessive-compulsive disorder
- Posttraumatic stress disorder
- Tourette disorder
- Chronic pain syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Soterix Medical
Lead Sponsor
Columbia University
Collaborator