NCT05583747Recruiting
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)
Source: ClinicalTrials.gov · Last updated 26 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 8 Jun 2022
- Start date
- 24 Oct 2022
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Depression
- NCT number
- NCT05583747
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 24 Oct 2022 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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).
Lab values
- present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator
Other
- are pregnant or intend to become pregnant during the study
- have inadequate English fluency to complete clinical assessments.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Poul Hansen Family Centre for Depression, Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.