Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

Not Applicable

Not yet recruiting

• Conditions: Depression
• Interventions: Device: Transcranial Magnetic Simulation; Device: Mixed reality neuronavigation

• Registration Number: NCT04730180
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-29
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07
• Study Start: 2024-01-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female subjects ages 18-75.
2. 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.
3. Healthy subjects with no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs.
4. Clinical subjects with a diagnosis of treatment resistant depression and prescribed a clinical course of treatment with rTMS.

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Exclusion Criteria

1. 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.
2. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mixed reality neuronavigation	Mixed reality neuronavigation	For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.
No neuronavigation	Transcranial Magnetic Simulation	For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via scalp measurements.
Mixed reality neuronavigation	Transcranial Magnetic Simulation	For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.

Primary Outcome Measures

Name	Time	Method
Number of participants with response to TMS	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States