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

University of Messina

Status: Terminated

Conditions: Healthy

Treatments: Device: 1.5 mA tDCS; Device: Sham tDCS; Device: 1 mA tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04994379

Tongue Motor Cortex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups

1 mA tDCS

Experimental group

Description:

Participants receive the stimulation with an intensity of 1 mA.

Treatment:

Device: 1 mA tDCS

1.5 mA tDCS

Experimental group

Description:

Participants receive the stimulation with an intensity of 1.5 mA.

Treatment:

Device: 1.5 mA tDCS

Sham tDCS

Sham Comparator group

Description:

Participants receive the sham stimulation (zero electric current after a short initial increase).

Treatment:

Device: Sham tDCS