Healthy Young AdultsBoMAP NIBSNCT07431697
Boosting and Mapping Non-invasive Brain Stimulation Techniques
A study testing Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) in people with Healthy Young Adults, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial summary
In this study we applied TMS to the hand area of M1 whilst acquiring fMRI of the brain. This study tested whether a higher-frequency form of brain stimulation, called high-gamma (100Hz) intermittent theta burst stimulation (iTBS), more effectively increases brain excitability than the standard 50Hz iTBS. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2023to 12 Apr 2024
- 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
- Right handed
Who cannot join
- Contraindications to either TMS or MRI:
- Pregnant Metal implants Use of recreational drugs Neurological conditions History of seizures or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boosting and Mapping Non-invasive Brain Stimulation-induced Plasticity in Humans
In this study we applied TMS to the hand area of M1 whilst acquiring fMRI of the brain. This study tested whether a higher-frequency form of brain stimulation, called high-gamma (100Hz) intermittent theta burst stimulation (iTBS), more effectively increases brain excitability than the standard 50Hz iTBS. In a double-blind, randomized study with 22 healthy participants, brain activity and motor responses were measured using TMS-fMRI. The 100Hz iTBS condition produced stronger and more consistent increases in motor excitability and greater activation of sensorimotor brain regions compared to 50Hz and sham stimulation, suggesting it may be a more effective approach for non-invasive neuromodulation.
Read the detailed description
This study investigates whether a modified form of brain stimulation called high-gamma intermittent theta burst stimulation (iTBS) can more effectively and consistently increase brain excitability compared to the standard iTBS protocol. iTBS is a non-invasive method that uses magnetic pulses to influence brain activity, but responses vary widely between people.
In this double-blind, randomized, within-subject study, 22 healthy adults completed three sessions of brain stimulation combined with functional MRI (TMS-fMRI). Each participant received conventional 50Hz iTBS, high-gamma 100Hz iTBS, and a sham (placebo) condition on separate visits. Changes in motor cortex excitability were measured using motor-evoked potentials (MEPs), and brain activity and connectivity were assessed using fMRI.
The results showed that 100Hz iTBS produced stronger and more reliable increases in cortical excitability compared to both the 50Hz and sham conditions. High-gamma iTBS also activated broader areas of the sensorimotor network and showed stronger links between stimulation strength and neural response. These findings suggest that high-gamma iTBS may be a more effective and physiologically relevant approach for non-invasive brain stimulation in humans.
- Conditions
- Healthy Young Adults
- Being tested
- Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)Device
Also called iTBS, rTMS
iTBS applies a train of 3 pulses of stimulation, delivered at a gamma frequency, then repeated 10x at a theta repetition rate. Intensity of stimulation is personalized based on the individual's resting motor threshold, determined at the start of the session and delivered at 70% of this.
| Study group | Role | What they receive |
|---|---|---|
| 100Hz iTBS (intermittent theta burst protocol of rTMS) | Experimental | The high-frequency of the stimulation is what distinguishes it from the other stimulation types and it is the goal of the study to see if this stimulation protocol is more effective than the classical protocol Receives: Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) |
| 50Hz iTBS (intermittent theta burst protocol of rTMS) | Active comparator | The classical low-frequency protocol of stimulation, this one is being used to compare to the novel high-frequency protocol Receives: Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) |
| Sham iTBS (intermittent theta burst protocol of rTMS) | Sham comparator | The sham stimulation was delivered with a 50Hz iTBS protocol except that the stimulation intensity was halved so as to retain the sensation of stimulation whilst not activating neurons Receives: Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI)
fMRI of the brain and spinal chord were acquired during stimulation with single pulse TMS to elucidate the changes in BOLD activity occurring from the intervention.
Measured: Throughout the whole experiment, for a total of 26 minutes
Motor evoked potentials (MEPs)
When single pulses of TMS are applied to M1 hand region, MEPs are evoked in the corresponding hand muscle which can be measured with electromyography (EMG). The amplitude of the MEPs before and after the iTBS interventions are then measured and compared to determine the response to the iTBS, whether this is facilitation, suppression, or no change.
Measured: MEPs are measured for 8mins immediately before intervention, then 15 minutes after intervention for a further 8 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start2 Feb 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Friedhelm Hummel, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431697
- Sponsor's protocol ID
- 2021-01887
- Acronym
- BoMAP NIBS
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting and Mapping Non-invasive Brain Stimulation-induced Plasticity in Humans
- ClinicalTrials.gov ID
- NCT07431697
- Acronym / sponsor ID
- BoMAP NIBS / 2021-01887
- Conditions
- Healthy Young Adults
- Keywords
- Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 24 Feb 2026 (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.
In this study we applied TMS to the hand area of M1 whilst acquiring fMRI of the brain. This study tested whether a higher-frequency form of brain stimulation, called high-gamma (100Hz) intermittent theta burst stimulation (iTBS), more effectively increases brain excitability than the standard 50Hz iTBS. In a double-blind, randomized study with 22 healthy participants, brain activity and motor responses were measured using TMS-fMRI. The 100Hz iTBS condition produced stronger and more consistent increases in motor excitability and greater activation of sensorimotor brain regions compared to 50Hz and sham stimulation, suggesting it may be a more effective approach for non-invasive neuromodulation.
Detailed description
This study investigates whether a modified form of brain stimulation called high-gamma intermittent theta burst stimulation (iTBS) can more effectively and consistently increase brain excitability compared to the standard iTBS protocol. iTBS is a non-invasive method that uses magnetic pulses to influence brain activity, but responses vary widely between people.
In this double-blind, randomized, within-subject study, 22 healthy adults completed three sessions of brain stimulation combined with functional MRI (TMS-fMRI). Each participant received conventional 50Hz iTBS, high-gamma 100Hz iTBS, and a sham (placebo) condition on separate visits. Changes in motor cortex excitability were measured using motor-evoked potentials (MEPs), and brain activity and connectivity were assessed using fMRI.
The results showed that 100Hz iTBS produced stronger and more reliable increases in cortical excitability compared to both the 50Hz and sham conditions. High-gamma iTBS also activated broader areas of the sensorimotor network and showed stronger links between stimulation strength and neural response. These findings suggest that high-gamma iTBS may be a more effective and physiologically relevant approach for non-invasive brain stimulation in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100Hz iTBS (intermittent theta burst protocol of rTMS) | Experimental | Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)The high-frequency of the stimulation is what distinguishes it from the other stimulation types and it is the goal of the study to see if this stimulation protocol is more effective than the classical protocol |
| 50Hz iTBS (intermittent theta burst protocol of rTMS) | Active comparator | Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)The classical low-frequency protocol of stimulation, this one is being used to compare to the novel high-frequency protocol |
| Sham iTBS (intermittent theta burst protocol of rTMS) | Sham comparator | Device: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)The sham stimulation was delivered with a 50Hz iTBS protocol except that the stimulation intensity was halved so as to retain the sensation of stimulation whilst not activating neurons |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right handed
Key exclusion criteria (2 listed)
- Contraindications to either TMS or MRI:
- Pregnant Metal implants Use of recreational drugs Neurological conditions History of seizures or epilepsy
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 |
|---|---|---|
| Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)Also: iTBS, rTMSiTBS applies a train of 3 pulses of stimulation, delivered at a gamma frequency, then repeated 10x at a theta repetition rate. Intensity of stimulation is personalized based on the individual's resting motor threshold, determined at the start of the session and delivered at 70% of this. | Device | 100Hz iTBS (intermittent theta burst protocol of rTMS), 50Hz iTBS (intermittent theta burst protocol of rTMS), Sham iTBS (intermittent theta burst protocol of rTMS) |
Primary outcome
Functional magnetic resonance imaging (fMRI)
Time frame: Throughout the whole experiment, for a total of 26 minutes
fMRI of the brain and spinal chord were acquired during stimulation with single pulse TMS to elucidate the changes in BOLD activity occurring from the intervention.
Motor evoked potentials (MEPs)
Time frame: MEPs are measured for 8mins immediately before intervention, then 15 minutes after intervention for a further 8 minutes.
When single pulses of TMS are applied to M1 hand region, MEPs are evoked in the corresponding hand muscle which can be measured with electromyography (EMG). The amplitude of the MEPs before and after the iTBS interventions are then measured and compared to determine the response to the iTBS, whether this is facilitation, suppression, or no change.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) in people with Healthy Young Adults, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 2026. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional magnetic resonance imaging (fMRI) (time frame: Throughout the whole experiment, for a total of 26 minutes). The study lists 2 primary outcomes in all. 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 22 Sep 2026.