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

NCT04994379 | Terminated

• 1 other identifier: Tongue Motor Cortex
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Perceived appetite; tDCS; Submental muscle; M1

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (3)

1 mA tDCS

EXPERIMENTAL

Participants receive the stimulation with an intensity of 1 mA.

Device: 1 mA tDCS

1.5 mA tDCS

EXPERIMENTAL

Participants receive the stimulation with an intensity of 1.5 mA.

Device: 1.5 mA tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

1 mA tDCS DEVICE

One session with stimulation intensity of 1 mA.

1 mA tDCS

1.5 mA tDCS DEVICE

One session with stimulation intensity of 1.5 mA.

1.5 mA tDCS

Sham tDCS DEVICE

One session of sham stimulation.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal weight, based on the Body Mass Index (BMI)
• Males and females between 18 and 35

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, Sicily, 98121, Italy

Location

Study Officials

• Carmelo Mario Vicario, PhD

  University of Messina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 6, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: February 1, 2022
• Last Updated: December 16, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)