NeuromodulationNCT06464445
Optimization of ITBS for Depression
A study testing Monophasic iTBS, Biphasic iTBS and Monophasic-Long iTBS in people with Neuromodulation, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromodulation
- What is being tested?
- Monophasic iTBS, Biphasic iTBS and Monophasic-Long iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 35 years old
- Be of right manual dominance
- In good health
Who cannot join
- 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,
Show all 14Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du Centre hospitalier universitaire de Sherbrook
Sherbrooke, Quebec, J1H 5H3
Samantha Cote, Samantha.cote@usherbrooke.ca
About this study
Official title: Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression
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
- Being tested
- Monophasic iTBS, Biphasic iTBS, Monophasic-Long iTBS
- Keywords
- TMS, repetitive TMS, intermittent Theta Burst Stimulation, Plasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monophasic iTBSDevice
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 iTBSDevice
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 iTBSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Monophasic iTBS; Device: Biphasic iTBS; Device: Monophasic-Long iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated Measure Design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-François Lepage, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464445
- Sponsor's protocol ID
- 2024-5470
- Status last verified
- Aug 2024
- First submitted
- 12 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression
- ClinicalTrials.gov ID
- NCT06464445
- Acronym / sponsor ID
- 2024-5470
- Conditions
- Neuromodulation
- Keywords
- TMS, repetitive TMS, intermittent Theta Burst Stimulation, Plasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated Measure Design
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation (iTBS) | Experimental | Device: Monophasic iTBS, Device: Biphasic iTBS, Device: Monophasic-Long iTBSAll participants will understand 3 different iTBS protocols, each separated by one week. The order of the iTBS protocols will be randomized. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between 18 and 35 years old
- Be of right manual dominance
- In good health
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monophasic iTBSiTBS 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 | Device | Intermittent theta burst stimulation (iTBS) |
| Biphasic iTBSiTBS 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 | Device | Intermittent theta burst stimulation (iTBS) |
| Monophasic-Long iTBSiTBS 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 | Device | Intermittent theta burst stimulation (iTBS) |
Primary outcome
TMS derived measure of cortical plasticity
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monophasic iTBS, Biphasic iTBS and Monophasic-Long iTBS in people with Neuromodulation, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Cote, Ph.D. (819-346-1110 ext. 70184, Samantha.cote@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMS derived measure of cortical plasticity (time frame: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.