NCT07431697

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

February 19, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    MEPs are measured for 8mins immediately before intervention, then 15 minutes after intervention for a further 8 minutes.

Study Arms (3)

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

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

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

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

Interventions

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.

Also known as: iTBS, rTMS
100Hz iTBS (intermittent theta burst protocol of rTMS)50Hz iTBS (intermittent theta burst protocol of rTMS)Sham iTBS (intermittent theta burst protocol of rTMS)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right handed

You may not qualify if:

  • Contraindications to either TMS or MRI:
  • Pregnant Metal implants Use of recreational drugs Neurological conditions History of seizures or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Biotech

Geneva, Canton of Geneva, 1202, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 24, 2026

Study Start

February 2, 2023

Primary Completion

April 12, 2024

Study Completion

April 12, 2024

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations