The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT.
Inclusion Criteria:
- Have unipolar depressive episode based on the MINI with or without psychotic symptoms
- Have previous response to ECT or high symptom severity warranting acute ECT in the
opinion of a consultant brain stimulation psychiatrist
- Are over the age of 18
- Pass the TMS adult safety screening (TASS) questionnaire
- Are voluntary and competent to consent to treatment
Exclusion Criteria:
- Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of
substance dependence or abuse within the last 1 month
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted
medication pump
- Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of
bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform
disorder, delusional 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 except those therapeutically induced by
ECT or a febrile seizure of infancy or single seizure related to a known drug related
event, cerebral aneurysm, or significant head trauma with loss of consciousness for
greater than 5 minutes
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear
implants, or electrodes) or any other metal object within or near the head, excluding
the mouth, that cannot be safely removed
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an
anticonvulsant due to the potential to limit rTMS efficacy
- Lack of response to accelerated course of iTBS or rTMS in the past
CAMH
Toronto, Ontario, Canada
Daniel Blumberger, MD, Principal Investigator
CAMH