Optimization of ITBS for Depression

NCT ID: NCT06464445

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromodulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repeated Measure Design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Monophasic iTBS

Intervention Type 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

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Jean-François Lepage

Full professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre de recherche du Centre hospitalier universitaire de Sherbrook

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Samantha Cote, Ph.D.

Role: CONTACT

819-346-1110 ext. 70184

Jean-Francois Lepage, Ph.D.

Role: CONTACT

819-346-1110 ext. 71020

Facility Contacts

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Samantha Cote

Role: primary

Other Identifiers

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2024-5470

Identifier Type: -

Identifier Source: org_study_id

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