Optimization of ITBS for Depression

February 5, 2025 updated by: Jean-François Lepage, Université de Sherbrooke

Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression

Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression.

Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied.

The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Recruiting
        • Centre de recherche du Centre hospitalier universitaire de Sherbrook
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be between 18 and 35 years old
  • Be of right manual dominance
  • In good health

Exclusion Criteria:

  • Have an implant or pacemaker,
  • Having tinnitus,
  • Have a history of fainting,
  • Have already had an epileptic seizure or have a family history of epilepsy,
  • Have a known neurological disease,
  • Be under psychotropic medication,
  • Have suffered from substance abuse or dependence in the last 6 months,
  • Have a neurostimulator,
  • Have a splinter or metallic implant in the head or the rest of the body,
  • Have a cochlear implant,
  • Have an automated injection system implanted (insulin pump),
  • Have a transdermal patch,
  • Have tattoos in the area to be studied,
  • Be pregnant or breastfeeding,

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent theta burst stimulation (iTBS)
All participants will understand 3 different iTBS protocols, each separated by one week. The order of the iTBS protocols will be randomized.
Device: Monophasic iTBS

iTBS protocol with monophasic-shaped pulses. iTBS parameters:

  • Intensity: 80% of resting motor threshold (rMT)
  • Frequency: 50 Hz
  • Duration of pulse train: 2 seconds
  • Interval between pulse trains: 8 seconds
Device: Biphasic iTBS

iTBS protocol with biphasic-shaped pulses. iTBS parameters:

  • Intensity: 80% of rMT
  • Frequency: 50 Hz
  • Duration of pulse train: 2 seconds
  • Interval between pulse trains: 8 seconds
Device: Monophasic-Long iTBS

iTBS protocol with long monophasic-shaped pulses. iTBS parameters:

  • Intensity: 80% of rMT
  • Frequency: 50 Hz
  • Duration of pulse train: 2 seconds
  • Interval between pulse trains: 8 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMS derived measure of cortical plasticity
Time Frame: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.
Change in Peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt, approximately 120% of rMT) after iTBS
Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

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)

August 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-5470

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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