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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06464445
Other study ID # 2024-5470
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2025

Study information

Verified date June 2024
Source Université de Sherbrooke
Contact Samantha Cote, Ph.D.
Phone 819-346-1110
Email Samantha.cote@usherbrooke.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
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
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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Outcome

Type Measure Description Time frame Safety issue
Primary TMS derived measure of cortical plasticity Change in Peak-to-peak motor evoked potential (MEP) amplitude induced by the administration est 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.
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