Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic

  • STATUS
    Recruiting
  • End date
    Sep 15, 2023
  • participants needed
    24
  • sponsor
    Ontario Shores Centre for Mental Health Sciences
Updated on 24 March 2022
Accepts healthy volunteers

Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.

Description

Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .

Details
Condition Treatment Resistant Depression
Treatment Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
Clinical Study IdentifierNCT04935489
SponsorOntario Shores Centre for Mental Health Sciences
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years and older
Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment

Exclusion Criteria

Have a MINI confirmed diagnosis of a substance use disorder within the last month
Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
Have a lifetime MINI diagnosis of bipolar I, or 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 taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
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