NCT04730180

Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

Evaluating the Effectiveness of Different Targeting Approaches for Transcranial Magnetic Stimulation Treatment of Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We aim to learn whether use of a mixed reality device for transcranial magnetic stimulation (TMS) targeting can improve treatment outcomes compared to targeting through scalp measurements or a commercial neuronavigation system. Prior studies indicate that neuronavigation can lead to improved treatment outcomes compared to scalp measurements, but neuronavigation adaption has been lacking due to the increased burden of the neuronavigation setup on the TMS operator. We will assess whether use of a mixed reality device can decrease that burden and speed up the neuronavigation process and is feasible to be used in a clinical setting.

Detailed description

Prior studies suggest that treatment efficacy for TMS treatment of depression is affected by the targeting method used to guide TMS coil placement. We will compare the treatment outcome for three patient groups. TMS coil placement is guided for group 1) with simple scalp measurement targeting, for group 2) with a mixed reality neuronavigation system. The treatment schedule for the medically prescribed TMS treatment for each patient are 30 daily weekday repetitive TMS treatments for 6 weeks with an additional 6 treatments tapered over 3 weeks.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Simulation	Brain stimulation treatment will be performed using FDA-cleared TMS coils according to their intended use of treatment of medication resistant depression by targeting the dorsolateral prefrontal cortex.
DEVICE	Mixed reality neuronavigation	Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2021-01-29
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study