Stanford University
Stanford, California, 94305, United States
NCT Number: NCT04730180
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.
Time frame: 9 weeks
We will count how many participants responded to TMS treatment in each arm. Response is measured as a more than 50% reduction in MADRS score per patient.
Contact information is provided by the study sponsor or research team.
Christoph Leuze, PhD
CONTACT
Jennifer A McNab, PhD
CONTACT
Stanford University
Other
Evaluating the Effectiveness of Different Targeting Approaches for Transcranial Magnetic Stimulation Treatment of Depression
Acronym: XRnav
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