Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression (XRnav)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Transcranial Magnetic Simulation; Device: Mixed reality neuronavigation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer A McNab, PhD; Phone Number: (650) 724-1195; Email: mcnabj@stanford.edu
• Study Contact Backup: Name: Christoph Leuze, PhD; Phone Number: 6502509332; Email: cleuze@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Contact: Jennifer A McNab; Phone Number: 650-724-1195; Email: mcnabj@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No neuronavigation; For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via scalp measurements.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with response to TMS	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.	9 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jennifer A McNab, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): July 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 60006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No