Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study
NCT ID: NCT04376697
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-03-18
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active rTMS
Treatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total.
Repetitive Transcranial Magnetic Stimulation (rTMS)
The treatment will be delivered by trained medical personnel.
Interventions
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Repetitive Transcranial Magnetic Stimulation (rTMS)
The treatment will be delivered by trained medical personnel.
Eligibility Criteria
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Inclusion Criteria
* are voluntary and competent to consent to treatment
* are between the ages of 18 and 85, inclusive
* are able to adhere to the treatment schedule
* pass the TMS safety-screening questionnaire
* have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening
Exclusion Criteria
* have a history of substance dependence or abuse within the last 3 months
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
* have a diagnosis of any psychotic disorder
* have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
* if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
* clinically significant laboratory abnormality, in the opinion of the investigator
* currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
* non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
* any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension
18 Years
85 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Jonathan Downar
Clinician scientist
Principal Investigators
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Jonathan Downar
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Eileen Lam
Role: primary
References
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Sheen JZ, Miron JP, Mansouri F, Dunlop K, Russell T, Zhou R, Hyde M, Fox L, Voetterl H, Daskalakis ZJ, Griffiths JD, Blumberger DM, Downar J. Cardiovascular biomarkers of response to accelerated low frequency repetitive transcranial magnetic stimulation in major depression. J Affect Disord. 2022 Dec 1;318:167-174. doi: 10.1016/j.jad.2022.08.105. Epub 2022 Aug 31.
Miron JP, Voetterl H, Fox L, Hyde M, Mansouri F, Dees S, Zhou R, Sheen J, Desbeaumes Jodoin V, Mir-Moghtadaei A, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F, Downar J. Optimized repetitive transcranial magnetic stimulation techniques for the treatment of major depression: A proof of concept study. Psychiatry Res. 2021 Apr;298:113790. doi: 10.1016/j.psychres.2021.113790. Epub 2021 Feb 7.
Other Identifiers
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18-6253.1
Identifier Type: -
Identifier Source: org_study_id