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TerminatedNCT04994379tDCSUpdated Dec 16, 2024

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

An interventional study of 1 mA tDCS and 1.5 mA tDCS in Healthy, sponsored by University of Messina. Terminated at 1 site in Italy. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by University of Messina · Not applicable, Interventional, and Basic science

Why this study was terminated
Working conditions.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Perceived appetite
  • tDCS
  • Submental muscle
  • M1
03

In context

Lead sponsor

University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    1 mA tDCS

    Participants receive the stimulation with an intensity of 1 mA.

    Device: 1 mA tDCS

  • Experimental
    1.5 mA tDCS

    Participants receive the stimulation with an intensity of 1.5 mA.

    Device: 1.5 mA tDCS

  • Sham comparator
    Sham tDCS

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

    Device: Sham tDCS

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.

06

What researchers measure

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.

    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

  1. 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

    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)

07

Study locations

1 site
  • University of Messina
    Messina, Sicily 98121, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04994379
Lead sponsor
University of Messina
Responsible party
Abed Hadipour Lakmehsari (Principal Investigator, University of Messina) — Principal investigator
First posted
Aug 6, 2021
Start date
Aug 1, 2021
Primary completion
Sep 1, 2021
Completion
Feb 1, 2022
Last update
Dec 16, 2024

Study contacts

Carmelo Mario Vicario, PhD
study director · University of Messina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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