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Working conditions.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mA tDCS | Experimental | Participants receive the stimulation with an intensity of 1 mA. |
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| 1.5 mA tDCS | Experimental | Participants receive the stimulation with an intensity of 1.5 mA. |
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| Sham tDCS | Sham Comparator | Participants receive the sham stimulation (zero electric current after a short initial increase). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 mA tDCS | Device | One session with stimulation intensity of 1 mA. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the subjective rating of appetite | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in excitability of the submental muscle region in primary motor cortex | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Mario Vicario, PhD | University of Messina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Messina | Messina | Sicily | 98121 | Italy |
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Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
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| 1.5 mA tDCS |
| Device |
One session with stimulation intensity of 1.5 mA. |
|
| Sham tDCS | Device | One session of sham stimulation. |
|
| 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) |