E-field Guided iTBS for Depression

N/A

Recruiting

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre- and post-intervention (average of 6 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if personalizing rTMS helps improve treatment response in people with mental health issues.

Who is the study for?

This trial is for adults aged 18-65 with major depressive disorder who haven't responded to certain antidepressants. They must score ≥18 on the HRSD-17, be outpatients, consent to treatment, and keep their current medication stable. Exclusions include unstable medical conditions, pregnancy, metal implants affecting MRI or TMS safety, inadequate English fluency, recent psychotherapy changes, certain psychiatric diagnoses or substance use disorders.

What is being tested?

The study tests personalized repetitive transcranial magnetic stimulation (rTMS) using intermittent theta burst stimulation (iTBS). Participants will receive iTBS either with standard targeting/intensity or tailored to individual brain activity markers via MRI and E-field modeling measures.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of rTMS can include headaches, scalp discomfort at the site of stimulation, lightheadedness and rare risk of seizure. Personal experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre- and post-intervention (average of 6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre- and post-intervention (average of 6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre- and post-intervention (average of 6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mental Depression

Markers of cortical excitation

Secondary study objectives

Tumor Markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Course A: E-field ModelingExperimental Treatment1 Intervention

Your Magnetic Resonance Image (MRI) results and rTMS calibration information (motor threshold) will be used to create a brain model and identify the targeted location, iTBS coil position and intensity for your iTBS rTMS treatment. You will undergo iTBS rTMS treatment in this study for 6 weeks. There will be 5 iTBS treatment sessions per week, lasting approximately 3 minutes each, once daily for 5 days in a row (always Monday to Friday). Each day after treatment, you will also complete a brief set of questionnaires to track your symptoms, which will take 15 minutes. After every 5 treatments, you will complete an extra interview that will take an additional 30 minutes. There will also be two follow-up visits at 1 and 4 weeks after the end of treatment, each lasting approximately 1 hour. During these follow-up visits, you will be asked to complete a brief set of questionnaires and interviews to monitor your symptoms.

Group II: Treatment Course B: Beam F3Active Control1 Intervention

The targeted iTBS rTMS treatment location and intensity will be determined via standard parameters, specifically anatomical landmarks and your rTMS calibration information (motor threshold). You will undergo iTBS rTMS treatment in this study for 6 weeks. There will be 5 iTBS treatment sessions per week, lasting approximately 3 minutes each, once daily for 5 days in a row (always Monday to Friday). Each day after treatment, you will also complete a brief set of questionnaires to track your symptoms, which will take 15 minutes. After every 5 treatments, you will complete an extra interview that will take an additional 30 minutes. There will also be two follow-up visits at 1 and 4 weeks after the end of treatment, each lasting approximately 1 hour. During these follow-up visits, you will be asked to complete a brief set of questionnaires and interviews to monitor your symptoms.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iTBS

2019

Completed Phase 3

~640

Do I qualify?Apply below to find out