What this study is
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.
What's being tested
- Transcranial Magnetic Simulation
Intervention · DEVICE
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.
- Mixed reality neuronavigation
Intervention · DEVICE
Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.
Study details
- Official title
- Evaluating the Effectiveness of Different Targeting Approaches for Transcranial Magnetic Stimulation Treatment of Depression
- Sponsor
- Stanford University
- Conditions
- Depression
- Enrolling
- 60 people
- Starts
- 2024-01-01
- Est. completion
- 2026-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female subjects ages 18-75.
- MRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging. All potential subjects for the MRI component will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) or the Lucas Center. Those subjects who present no contraindications to being scanned will be allowed to participate.
- Healthy subjects with no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs.
- Clinical subjects with a diagnosis of treatment resistant depression and prescribed a clinical course of treatment with rTMS.
You can't join if
- Any contraindication to being scanned in the 3.0T scanner at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at 3.0 Tesla.
- History of neurological disorders including but not limited to brain surgery, deep brain stimulation, radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, head trauma.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStanford University
Stanford, California, United States
- Jennifer A McNab · Contact650-724-1195mcnabj@stanford.edu
Study team
Sponsor
Stanford University
Study ID 60006
Principal investigator
Jennifer A McNab, PhD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.