Optimization of ITBS for Depression

Not Applicable

Recruiting

• Conditions: Neuromodulation
• Interventions: Device: Monophasic iTBS; Device: Biphasic iTBS; Device: Monophasic-Long iTBS

• Registration Number: NCT06464445
• Lead Sponsor: Université de Sherbrooke

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermittent theta burst stimulation (iTBS)	Monophasic-Long iTBS	All participants will understand 3 different iTBS protocols, each separated by one week. The order of the iTBS protocols will be randomized.
Intermittent theta burst stimulation (iTBS)	Biphasic iTBS	All participants will understand 3 different iTBS protocols, each separated by one week. The order of the iTBS protocols will be randomized.
Intermittent theta burst stimulation (iTBS)	Monophasic iTBS	All participants will understand 3 different iTBS protocols, each separated by one week. The order of the iTBS protocols will be randomized.

Primary Outcome Measures

Name	Time	Method
TMS derived measure of cortical plasticity	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

Trial Locations

Locations (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrook; 🇨🇦 Sherbrooke, Quebec, Canada