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

March 22, 2023 updated by: Dr. Robyn Waxman, Ontario Shores Centre for Mental Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Whitby, Ontario, Canada, M5P 3L9
        • Robyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving accelerated rTMS
Device: Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Time Frame: at screening (within a week of starting treatment) to a week post treatment
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
at screening (within a week of starting treatment) to a week post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Time Frame: at screening (within a week of starting treatment) to a week post treatment
Change in severity of depressive symptoms (same as primary outcome description)
at screening (within a week of starting treatment) to a week post treatment
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Time Frame: at screening (within a week of starting treatment) to a week post treatment
Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21
at screening (within a week of starting treatment) to a week post treatment
Change in World Health Organization Disability assessment scale (WHODAS)
Time Frame: at screening (within a week of starting treatment) to a week post treatment
severity of disability ( 40 to 180 - higher score = more disabled)
at screening (within a week of starting treatment) to a week post treatment
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Time Frame: at screening (within a week of starting treatment) to a week post treatment
Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)
at screening (within a week of starting treatment) to a week post treatment
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Time Frame: at screening (within a week of starting treatment) to a week post treatment
Change in severity of illness (1 - much worse, 7 - most improved)
at screening (within a week of starting treatment) to a week post treatment
Patient Health Questionnaire (PHQ-9) - Response to symptoms
Time Frame: at screening (within a week of starting treatment ) to a week post treatment
reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27
at screening (within a week of starting treatment ) to a week post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects of the treatment
Time Frame: during and after each rTMS treatment during acute treatment and up to a week after treatment
Looking at occurrence of adverse effects - screened during/after each treatment
during and after each rTMS treatment during acute treatment and up to a week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Shores Centre for Mental Health Sciences

Investigators

  • Principal Investigator: Robyn Waxman, Ontario Shores

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-008-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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