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

Primary Purpose

Depression

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Magnetic Simulation

Mixed reality neuronavigation

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

No neuronavigation

Mixed reality neuronavigation

Arm Description

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

For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04730180

First Posted

January 21, 2021

Last Updated

May 4, 2021

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04730180

Brief Title

Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

Acronym

XRnav

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

July 31, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No neuronavigation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mixed reality neuronavigation

Arm Type

Active Comparator

Arm Description

For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.

Intervention Type

Device

Intervention Name(s)

Transcranial Magnetic Simulation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Mixed reality neuronavigation

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with response to TMS

Description

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.

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer A McNab, PhD

Phone

(650) 724-1195

mcnabj@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Leuze, PhD

Phone

6502509332

cleuze@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer A McNab, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer A McNab

Phone

650-724-1195

mcnabj@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

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