Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

University Health Network, Toronto

Status

Unknown

Conditions

Depressive Disorder

Treatments

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT04376697

18-6253.1

Details and patient eligibility

About

This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

are outpatients
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

previous rTMS treatment
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