12 Participants Needed

Virtual Reality-Guided TMS for Depression

MM
AD
YG
DT
RM
Overseen ByRashel Mejia, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

My depression hasn't improved after trying two or more treatments and TMS.
At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
I have been diagnosed with major depression.

Exclusion Criteria

I take medication that doesn't allow me to have TMS treatment.
My health is stable; no recent issues found in exams or tests.
Contraindications to MRI (based on metal screening form)
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TMS treatment targeting the L-DLPFC using either virtual or on-line neuro-navigation

6 weeks
2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Neuro-navigated Transcranial Magnetic Stimulation (TMS)
Trial Overview The study tests a virtual neuro-navigation system designed to improve the precision of TMS treatment for depression. It's a Phase I trial focusing on how well this new technology identifies specific brain targets to enhance the effectiveness of TMS.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: virtual neuro-navigationExperimental Treatment1 Intervention
The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area.
Group II: on-line neuro-navigationExperimental Treatment1 Intervention
The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area.

Neuro-navigated Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Navigated TMS for:
  • Major Depressive Disorder (MDD)
  • Obsessive-Compulsive Disorder (OCD)
  • Chronic Pain Syndrome
🇪🇺
Approved in European Union as Neuro-navigated TMS for:
  • 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

Trials
12
Recruited
410+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Findings from Research

Transcranial magnetic stimulation (TMS) is a non-invasive brain imaging technique that can causally link specific cortical areas to physiological responses, making it more precise than other imaging methods.
Navigated TMS has shown clinical effectiveness in mapping motor areas, assessing recovery after stroke, and treating conditions like depression, but further development of targeting and dosing protocols is needed for improved accuracy and reproducibility in clinical settings.
Navigated transcranial magnetic stimulation.Ruohonen, J., Karhu, J.[2016]
Transcranial magnetic stimulation (nTMS) was effectively used for preoperative functional mapping in 10 patients with rolandic tumors, showing reliable results that corresponded well with direct cortical stimulation, the current gold standard.
The average safety margin between the tumor and the nearest motor response was similar for both nTMS (7.9 mm) and direct cortical stimulation (6.6 mm), indicating that nTMS can be a precise tool for surgical planning in motor cortex tumor surgeries.
Navigated transcranial magnetic stimulation for preoperative functional diagnostics in brain tumor surgery.Picht, T., Mularski, S., Kuehn, B., et al.[2022]
The study found that the 'standard' procedure for positioning TMS coils inaccurately targeted the dorsolateral premotor cortex (dlPMC) and dorsolateral prefrontal cortex (dlPFC) in many patients, with errors of about 1 to 2 cm, which could affect treatment outcomes.
Using a neuronavigation system that accounts for individual brain anatomy significantly improved the accuracy of targeting these regions, suggesting that more precise coil placement could enhance the efficacy of TMS treatments for depression.
Comparison of "standard" and "navigated" procedures of TMS coil positioning over motor, premotor and prefrontal targets in patients with chronic pain and depression.Ahdab, R., Ayache, SS., Brugières, P., et al.[2015]

References

Navigated transcranial magnetic stimulation. [2016]
Navigated transcranial magnetic stimulation for preoperative functional diagnostics in brain tumor surgery. [2022]
Comparison of "standard" and "navigated" procedures of TMS coil positioning over motor, premotor and prefrontal targets in patients with chronic pain and depression. [2015]
Implementing Functional Preoperative Mapping in the Clinical Routine of a Neurosurgical Department: Technical Note. [2022]
Introducing navigated transcranial magnetic stimulation as a refined brain mapping methodology. [2019]
Safety and tolerability of navigated TMS for preoperative mapping in neurosurgical patients. [2022]
Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. [2022]
Neuronavigation increases the physiologic and behavioral effects of low-frequency rTMS of primary motor cortex in healthy subjects. [2022]
The use of MR‑less MNI based neuronavigation for 10 Hz rTMS depression therapy: electrophysiological and clinical implications. [2019]
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