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RecruitingNCT06464445Updated Feb 10, 2025

Optimization of ITBS for Depression

An interventional study of Monophasic iTBS and Biphasic iTBS in Neuromodulation, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neuromodulation

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Keywords

  • TMS
  • repetitive TMS
  • intermittent Theta Burst Stimulation
  • Plasticity
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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,
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Device: Biphasic iTBS · Device: Monophasic-Long iTBS

Interventions

  • DeviceMonophasic 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

  • DeviceBiphasic 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

  • DeviceMonophasic-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

06

What researchers measure

Primary outcomes

  1. TMS derived measure of cortical plasticity

    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

    Time frame: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.

07

Study locations

1 of 1 sites recruiting
  • Centre de recherche du Centre hospitalier universitaire de Sherbrook
    Sherbrooke, Quebec J1H 5H3, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06464445
Lead sponsor
Université de Sherbrooke
Responsible party
Jean-François Lepage (Full professor, Department of Pediatrics, Université de Sherbrooke) — Principal investigator
First posted
Jun 18, 2024
Start date
Aug 1, 2024
Primary completion
Dec 1, 2025 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Feb 10, 2025

Study contacts

Samantha Cote, Ph.D.
Contact
Samantha.cote@usherbrooke.ca
819-346-1110 ext. 70184
Jean-Francois Lepage, Ph.D.
Contact
jean-francois.lepage@usherbrooke.ca
819-346-1110 ext. 71020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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