Healthy
Conditions
Keywords
Perceived appetite, tDCS, Submental muscle, M1
Brief summary
This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.
Detailed description
After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.
Interventions
DEVICE1 mA tDCS
One session with stimulation intensity of 1 mA.
DEVICE1.5 mA tDCS
One session with stimulation intensity of 1.5 mA.
DEVICESham tDCS
One session of sham stimulation.
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal weight, based on the Body Mass Index (BMI) * Males and females between 18 and 35
Exclusion criteria
* Use of psychoactive drugs * Presence of metal implants in the brain, skull, scalp or neck * Use of pacemaker * Neurological or psychiatric pathologies * History of severe head injury * Pregnancy * Clinical obesity based on BMI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the subjective rating of appetite | Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour) | A visual analogue scale (VAS; from 0 meaning not hungry at all, to 100 meaning extremely hungry), will be used to record the perceived level of hunger before and after the stimulation to enable evaluation of the effects of stimulation on perceived appetite. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in excitability of the submental muscle region in primary motor cortex | Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour) | Recording motor evoked potentials from the area of the submental region of the motor cortex in addition to a control site (APB muscle), to allow for comparisons of the amplitude of MEPs before and after stimulation to draw conclusions about the effect of stimulation and its contribution to the potential behavioral modulations of tDCS |
Countries
Italy
Outcome results
None listed