Optimization of iTBS for Depression

Neuromodulation Clinical Trial

Official title:

Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464445
• Other study ID #: 2024-5470
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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,

Related Conditions & MeSH terms

• Depression
• Neuromodulation

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.