- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431697
Boosting and Mapping Non-invasive Brain Stimulation Techniques (BoMAP NIBS)
Boosting and Mapping Non-invasive Brain Stimulation-induced Plasticity in Humans
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1202
- Campus Biotech
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 100Hz iTBS (intermittent theta burst protocol of 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
|
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:
|
|
Active Comparator: 50Hz iTBS (intermittent theta burst protocol of rTMS)
The classical low-frequency protocol of stimulation, this one is being used to compare to the novel high-frequency protocol
|
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:
|
|
Sham Comparator: Sham iTBS (intermittent theta burst protocol of 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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Throughout the whole experiment, for a total of 26mins
|
|
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.
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MEPs are measured for 8mins immediately before intervention, then 15mins after intervention for a further 8mins.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-01887
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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