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

NCT ID: NCT04994379

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Perceived appetite tDCS Submental muscle M1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 mA tDCS

Participants receive the stimulation with an intensity of 1 mA.

Group Type EXPERIMENTAL

1 mA tDCS

Intervention Type DEVICE

One session with stimulation intensity of 1 mA.

1.5 mA tDCS

Participants receive the stimulation with an intensity of 1.5 mA.

Group Type EXPERIMENTAL

1.5 mA tDCS

Intervention Type DEVICE

One session with stimulation intensity of 1.5 mA.

Sham tDCS

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

One session of sham stimulation.

Interventions

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1 mA tDCS

One session with stimulation intensity of 1 mA.

Intervention Type DEVICE

1.5 mA tDCS

One session with stimulation intensity of 1.5 mA.

Intervention Type DEVICE

Sham tDCS

One session of sham stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Abed Hadipour Lakmehsari

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmelo Mario Vicario, PhD

Role: STUDY_DIRECTOR

University of Messina

Locations

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University of Messina

Messina, Sicily, Italy

Site Status

Countries

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Italy

Other Identifiers

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Tongue Motor Cortex

Identifier Type: -

Identifier Source: org_study_id