Official Title
A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic
Brief Summary

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

Detailed Description

Treatment resistant bipolar depression is a leading cause of disability and socioeconomic
burden of disease, and current treatment options all suffer from critical deficiencies of
efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and
aLFR in particular has the potential to overcome many of these deficiencies, and is safe and
well-tolerated. Taken together with the reported findings of other groups, aLFR may be
feasible, tolerable, and capable of achieving comparable and potentially better remission
rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and
use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot
data in two patients previously responsive to ECT and data from the Cole et al. study suggest
that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve
remission in patients with severe depressive symptoms who would otherwise receive ECT.
Furthermore, there is a burden of being able to provide care to as many people as possible
based on severity of illness during the pandemic.

Active, not recruiting
Bipolar Depression

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 LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.

Eligibility Criteria

Inclusion Criteria:

- Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2)
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 one of the brain stimulation psychiatrists

- 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

- Currently experiencing a mixed or manic episode (YMRS >12)

- have a concomitant major unstable medical illness, cardiac pacemaker or implanted
medication pump

- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of
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, 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 rTMS in the past

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

CAMH
Toronto, Ontario, Canada

Daniel Blumberger, MD, Principal Investigator
CAMH

Centre for Addiction and Mental Health
NCT Number
Keywords
bipolar depression
transcranial magnetic stimulation
treatment resistance
low-frequency right-side stimulation
MeSH Terms
COVID-19
Depression
Depressive Disorder
Bipolar Disorder