Investigating the Effects of Intensity of Transcranial Direct Current Stimulation on Subjective Appetite

University of Messina64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

1 mA tDCSDEVICE

One session with stimulation intensity of 1 mA.

1.5 mA tDCSDEVICE

One session with stimulation intensity of 1.5 mA.

Sham tDCSDEVICE

One session of sham stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Messina

Messina, Sicily, Italy

Outcomes

Primary Outcomes

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.

Time frame: 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)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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