Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

NCT04730180 | Not Yet Recruiting FDA Device

• 1 other identifier: 60006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No neuronavigation

ACTIVE COMPARATOR

For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via scalp measurements.

Device: Transcranial Magnetic Simulation

Mixed reality neuronavigation

ACTIVE COMPARATOR

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; Device: Mixed reality neuronavigation

Interventions

Transcranial Magnetic Simulation 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; No neuronavigation

Mixed reality neuronavigation DEVICE

Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.

Mixed reality neuronavigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer A McNab, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer A McNab, PhD

CONTACT

(650) 724-1195; mcnabj@stanford.edu

Christoph Leuze, PhD

CONTACT

6502509332; cleuze@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 29, 2021
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)