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NCT Number: NCT06464445

Optimization of ITBS for 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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du Centre hospitalier universitaire de Sherbrook

Sherbrooke, Quebec, J1H 5H3, Canada

Location status: Recruiting

Location contact

Samantha Cote

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Monophasic iTBS

Device

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

Biphasic iTBS

Device

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

Monophasic-Long iTBS

Device

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Francois Lepage, Ph.D.

CONTACT

[email protected]

819-346-1110 ext. 71020

Samantha Cote, Ph.D.

CONTACT

[email protected]

819-346-1110 ext. 70184

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 18, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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