Optimization of ITBS for Depression

NCT06464445 | Recruiting

• 1 other identifier: 2024-5470
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromodulation

Keywords

TMS; repetitive TMS; intermittent Theta Burst Stimulation; Plasticity

Outcome Measures

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

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

Study Arms (1)

Intermittent theta burst stimulation (iTBS)

EXPERIMENTAL

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

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

Intermittent theta burst stimulation (iTBS)

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

Intermittent theta burst stimulation (iTBS)

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

Intermittent theta burst stimulation (iTBS)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrook

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

Central Study Contacts

Samantha Cote, Ph.D.

CONTACT

819-346-1110; Samantha.cote@usherbrooke.ca

Jean-Francois Lepage, Ph.D.

CONTACT

819-346-1110; jean-francois.lepage@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, Department of Pediatrics

Model Details: Repeated Measure Design

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-08

Locations

CA (1)