Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

February 16, 2024 updated by: Daniel Blumberger, Centre for Addiction and Mental Health
This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

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
      • Toronto, Ontario, Canada, M6J1H4
        • CAMH

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

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • are an outpatient
  • are ≥60 years old
  • have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current MDE
  • have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode or have failed to tolerate two separate trials of an antidepressant
  • have a score > 17 on the MADRS
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  • have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work
  • Pass the TMS adult safety screening (TASS) questionnaire
  • Are able to have an MRI

Exclusion Criteria:

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness determined by one of the study physicians
  • have active suicidal intent
  • have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
  • have current psychotic symptoms
  • have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary. One of these comorbidities will not be exclusionary if they are not deemed to be primary.
  • have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  • have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.
  • did not respond to a course of ECT in the current depressive episode
  • have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible
  • have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.
  • 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
  • have a implanted electronic device that is currently function such as a defibrillator
  • currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
  • 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
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Convential Sequential Bilateral rTMS

LFR followed by HFL.

1 Hz stimulation of the right DLPFC for 600 pulses followed by 10 Hz stimulation of the left DLPFC for 3000 pulses (4 seconds on 26 seconds off for 75 trains). Treatment will occur 5 times per week for 4 to 6 weeks.
Device: LFR followed by HFL
Magventure Cool B70 Coil with RX100 Stimulator
Experimental: Bilateral Theta Burst Stimulation

cTBS followed by iTBS.

continuous theta burst stimulation (cTBS) of the right DLPFC for 600 pulses followed by intermittent theta burst stimulation (iTBS) of the left DLPFC for 600 pulses. Treatment will occur 5 times per week for 4 to 6 weeks.
Device: cTBS followed by iTBS
Magventure Cool B70 Coil with RX100 Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: After 4 or 6 weeks
Change from baseline to week 4 or 6 endpoint
After 4 or 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission on the MADRS
Time Frame: After 4 or 6 weeks
Score less than or equal to 10
After 4 or 6 weeks

Collaborators and Investigators

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

Sponsor

Centre for Addiction and Mental Health

Collaborators

University Health Network, Toronto

Investigators

  • Principal Investigator: Daniel M. Blumberger, MD, CAMH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

December 1, 2016

Primary Completion (Actual)

April 24, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimated)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 076-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol and statistical analysis plan will be made available. Individual patient data will be made available once all primary and secondary analyses have been conducted by the study team.

IPD Sharing Time Frame

Individual patient data will be made available once all primary and secondary analyses have been conducted by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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