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

Healthy Clinical Trial

— tDCS  

Official title:

Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal tDCS on Appetite; A Double-blind Sham-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994379
• Other study ID #: Tongue Motor Cortex
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 2021

Study information

• Verified date: August 2021
• Source: University of Messina
• Contact: Abed Hadipour Lakmehsari, PhD
• Phone: 090 371 0722
• Email: ahadipourlakmehsari[@]unime.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 1 mA tDCS
One session with stimulation intensity of 1 mA.
• 1.5 mA tDCS
One session with stimulation intensity of 1.5 mA.
• Sham tDCS
One session of sham stimulation.

Locations

Country	Name	City	State
Italy	University of Messina	Messina	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Vicario CM, Rafal RD, Borgomaneri S, Paracampo R, Kritikos A, Avenanti A. Pictures of disgusting foods and disgusted facial expressions suppress the tongue motor cortex. Soc Cogn Affect Neurosci. 2017 Feb 1;12(2):352-362. doi: 10.1093/scan/nsw129. — View Citation

Vicario CM, Salehinejad MA, Mosayebi-Samani M, Maezawa H, Avenanti A, Nitsche MA. Transcranial direct current stimulation over the tongue motor cortex reduces appetite in healthy humans. Brain Stimul. 2020 Jul - Aug;13(4):1121-1123. doi: 10.1016/j.brs.2020.05.008. Epub 2020 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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)