Tests brain stimulation guided by MRI scans for hard-to-treat depression
Compares personalized magnetic brain stimulation with standard treatment in adults with depression.
Plain-language title generated from the registry record
Registry title: E-field Guided iTBS for Treatment Resistant Depression
Key facts
- Where
- Toronto, CanadaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05583747, who can take part
Where in Canada
- Centre for Addiction and Mental HealthToronto, CanadaTaking people
- Poul Hansen Family Centre for Depression, Toronto Western HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre for Addiction and Mental Health
- Trial code
- NCT05583747
- Record updated
- 26 September 2023
- Original description
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.Read full original descriptionShow less
Electrical Field Modeling to Engage Neurophysiological Targets of Intermittent Theta Burst Stimulation in Treatment Resistant Depression (E-Fields iTBS)
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.
Inclusion: 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: have a concomitant unstable medical illness; 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 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]; are participating in a new course psychotherapy initiated within the last 3 months or finishing prior to the end of scheduled treatments; 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; have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview); present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator; are pregnant or intend to become pregnant during the study; have inadequate English fluency to complete clinical assessments.