RecruitingNot ApplicableNCT05583747

E-field Guided iTBS for Treatment Resistant Depression

Electrical Field Modeling to Engage Neurophysiological Targets of Intermittent Theta Burst Stimulation in Treatment Resistant Depression (E-Fields iTBS)

Sponsor

Centre for Addiction and Mental Health

Enrollment

110 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

The purpose of this study is to establish how personalization of repetitive transcranial magnetic stimulation (rTMS) can change markers of brain activity and improve treatment response. To do this, all participants will receive the same active form of treatments, but some of the participants in this study will receive intermittent theta burst stimulation (iTBS) rTMS treatment with standard forms of targeting and intensity, and others will receive iTBS rTMS treatment using personalized magnetic resonance imaging (MRI) and electric field (E-field) modeling measures.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of non-invasive brain stimulation called E-field guided iTBS (a form of transcranial magnetic stimulation, or TMS) for people with treatment-resistant depression — meaning antidepressants haven't worked for them. The "E-field guided" approach uses brain imaging to more precisely target the stimulation. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with major depression - You have a Hamilton Depression Rating Scale score of 18 or higher (moderately severe) - You have tried at least one adequate course of antidepressant medication without sufficient benefit, or could not tolerate two different antidepressants - You are an outpatient and can consent voluntarily - You are willing to keep your current medications stable during the study **You may NOT be eligible if...** - You have metal implants in your head/neck that are incompatible with TMS - You have a history of seizures - You are currently taking medications that significantly lower seizure threshold - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTBS

rTMS involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. iTBS is a briefer form of patterned rTMS that has been shown to be effective against MDD, despite a stimulation period of 1-3 min rather than 30-40 min.