To confirm our previous findings that both TUS and auditory cuing decreases MEP amplitude in an independent sample using a more efficient design. Reducing the number of principal conditions will benefit data quality and allow for better estimation…
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- Other condition
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Health condition
Neuroscience research (basic science)
Research involving
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Intervention
Outcome measures
Primary outcome
We will use electromyography (EMG) to measure motor-evoked potentials (MEPs)
over the first dorsal interosseous (FDI) elicited by TMS applied over M1. Here,
MEP peak-to-peak amplitude is our primary outcome measure.
Secondary outcome
To determine how well participants are able to discriminate between the
ultrasound conditions (sham / active control / verum TUS), including when an
auditory mask is played on top of active control and verum TUS, participants
will be asked the following questions for 10 additional trials per condition:
*Do you think you received ultrasonic stimulation (yes/no)?* and *On which side
do you think you were stimulated (left/right)?*. Their accuracy/ability to
discriminate between conditions is the secondary outcome of this study.
Background summary
Transcranial ultrasonic stimulation (TUS) is a non-invasive brain stimulation
(NIBS) technique characterised by its superior spatial focality and ability to
reach both superficial and deep regions of the brain. At present, it is
important to confirm the fundamental neurophysiological effects of TUS. This
can be achieved by measuring the impact of TUS on the excitability of the
primary motor cortex (M1). Previous research has combined TUS with transcranial
magnetic stimulation (TMS) and observed a reduced amplitude of TMS-elicited
muscle twitches with TUS than without TUS. Considering the fundamental nature
of these findings, independent replications are required to confirm and expand
our understanding of the fundamental neurophysiological effects of TUS. In
fact, in a recently conducted study, we were able to replicate the original
findings, but could also offer a more parsimonious explanation for the observed
effects separating effects of specific neuromodulation and auditory cueing. In
the present study, we seek to confirm these initial findings in a design with a
reduced number of principal conditions to improve study efficiency. This effort
may help to better assess the neuromodulatory potential of ultrasound
stimulation and its auditory confounds to inform the experimental design of
future studies.
Study objective
To confirm our previous findings that both TUS and auditory cuing decreases MEP
amplitude in an independent sample using a more efficient design. Reducing the
number of principal conditions will benefit data quality and allow for better
estimation of effect size.
Study design
The present study will be a single-blind randomized sham-controlled trial. The
study consists of two sessions. The first session involves structural MRI
scans. The second session involves brain stimulation. In the brain stimulation
session, there are three within-subject factors. The first is TUS (sham TUS
[sound only] / active control TUS [contralateral face area stimulation] / verum
TUS [on-target hand area stimulation]). The second is stimulus duration (100ms
/ 500ms). The third is auditory masking (no masking/masking).
Intervention
Participants will receive TMS at standard supra-threshold intensity and TUS at
standard sub-threshold intensity.
Study burden and risks
Participants will receive no direct benefit from participating, though
participants will be financially compensated where applicable. However,
participants may see benefit in gaining first-hand experience with TUS. Before
participation, all subjects will be thoroughly screened for contraindications
for NIBS and MRI. TMS is a widely used NIBS technique and is associated with
minimal risk. There have been no reports of serious adverse events in healthy
participants when using protocols in accordance with published safety
guidelines (i.e., Rossi et al., 2020; see Donders NIBS SOP). The estimated risk
for participating in TUS experiments is minimal. TUS for human neuromodulation
has never resulted in serious adverse events (Pasquinelli et al., 2019). In
fact, there have been no reports of serious adverse events related to
diagnostic ultrasound either (ter Haar, 2010). Safety is further secured by
adherence of TUS experiments to internationally recognized guidelines (e.g.,
from the Food and Drug Administration) for diagnostic ultrasound. For both TMS
and TUS, minor side effects may include light transient headache and fatigue.
All in all, the risk and burden associated with participation is considered
minimal, and we do not expect any serious adverse events during the project.
Molukkenstraat 218
Nijmegen 6524NK
NL
Molukkenstraat 218
Nijmegen 6524NK
NL
Listed location countries
Age
Inclusion criteria
- Between 18-40 years of age
- Right handed
- The ability and agreement to provide informed consent, and the ability to
fulfil the study's requirements
Exclusion criteria
• Under 18 years of age
• Current pregnancy
• Claustrophobia
• A history or brain surgery or serious head trauma
• A history of or any close relatives (parents, siblings, children) with
epilepsy, convulsion, or seizure
• Predisposition for fainting spells (syncope)
• A cardiac pacemaker or intra-cardiac lines
• An implanted neurostimulator
• Implanted medication infusion device
• Implanted metal devices or large ferromagnetic fragments in the head or
upper body (excluding dental wire), or jewellery/piercing that cannot be
removed • Use of a medical plaster that cannot or may not be taken off (e.g.,
nicotine plaster)
• Cochlear implants
• Metal in the brain, skull, or elsewhere in your body (fragments, clips, etc.)
• Diagnosed neurological or psychiatric disorders
• Use of psychoactive (prescription) medication (excluding anti-conception)
• Skin disease at intended stimulation sites
• The consumption of more than four alcoholic units within 24 hours before
participation or any recreational drugs within 48 hours before participation
• All other criteria relevant to non-invasive brain stimulation as reported in
the Donders Standard Operating Procedures for Non-Invasive Brain
Stimulation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80331.091.22 |