Completed

NCT Number: NCT07431697

Boosting and Mapping Non-invasive Brain Stimulation Techniques

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.

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Key information

Conditions

Healthy Young Participants

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Biotech

Geneva, Canton of Geneva, 1202, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Right handed

Exclusion criteria

Contraindications to either TMS or MRI:

Pregnant Metal implants Use of recreational drugs Neurological conditions History of seizures or epilepsy

Treatment and study plan

Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS)

Device

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.

Other names: iTBS, rTMS

Primary outcomes

Functional magnetic resonance imaging (fMRI)

Time frame: Throughout the whole experiment, for a total of 26mins

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 15mins after intervention for a further 8mins.

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.

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Registry information

Official study title

Boosting and Mapping Non-invasive Brain Stimulation-induced Plasticity in Humans

Acronym: BoMAP NIBS

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Feb 24, 2026
Registry last updated: Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.