E-field Guided iTBS for Treatment Resistant Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iTBS.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Electrical Field Modeling to Engage Neurophysiological Targets of Intermittent Theta Burst Stimulation in Treatment Resistant Depression (E-Fields iTBS)
Overview
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.
Detailed description
The purpose of this study is to establish how personalization of rTMS can change markers of brain activity and improve treatment response in major depressive disorder (MDD). All participants will receive up to 30 iTBS treatments to the left dorsolateral prefrontal cortex (DLPFC), delivered daily, 5 days per week, for 6 weeks. Participants will be randomized to either a standard treatment arm, in which the iTBS targeting will be via the Beam F3 method to identify the left DLPFC location, and intensity will be determined as 120% of the resting motor threshold, or a personalized arm, in which the left DLPFC will be identified via functional magnetic resonance imaging (fMRI), the optimal coil position and stimulus intensity will be derived through E-Field modeling pipelines.
Interventions
- Device iTBS
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.
Primary outcome measures
- Markers of cortical excitation [Time frame: change from pre-intervention to post-intervention (average of 6 weeks)]
- Depression scores [Time frame: changes from baseline to Week 4 follow-up]
Secondary outcome measures (1)
- Peripheral biomarkers [Time frame: change from Pre- and post-intervention (average of 6 weeks)]
Eligibility criteria
Inclusion criteria
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
- are 18yo to 65yo;
- have a score of ≥18 on the Hamilton Rating Scale for Depression (HRSD-17) item at screening
- have not had a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2);
- are agreeable to keeping their current medication constant during the study
- are able to adhere to the study and treatment schedules
- meet TMS and MRI safety criteria
Exclusion criteria
- have a concomitant unstable medical illness
- are pregnant or intend to become pregnant during the study
- have a current MINI diagnosis of bipolar disorder, psychotic disorder, obsessive compulsive disorder, concurrent substance use disorder (aside from nicotine) or post-traumatic stress disorder (current or within the last year)
- have failed a course of electroconvulsive therapy within the current depressive episode due to the lower likelihood of response to rTMS;
- have any significant neurological disorder (e.g., space occupying brain lesion, history of stroke, cerebral aneurysm, seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis) or confirmed diagnosis of dementia or cognitive impairment
- present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator
- have an intracranial implant or any other metal object that cannot be safely removed, precluding safety of TMS or MRI exposure within or near the head, excluding the mouth
- require benzodiazepine equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS \[45\]
- have inadequate English fluency to complete clinical assessments.
- are participating in a new course psychotherapy initiated within the last 3 months or finishing prior to the end of scheduled treatments;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Poul Hansen Family Centre for Depression, Toronto Western Hospital — Toronto
- Centre for Addiction and Mental Health — Toronto
Identifiers
NCT: NCT05583747 · 3773