Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal TDCS on Appetite; a Double-blind Sham-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Messina
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in the subjective rating of appetite
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- 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
- •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
Arms & Interventions
1 mA tDCS
Participants receive the stimulation with an intensity of 1 mA.
Intervention: 1 mA tDCS (Device)
1.5 mA tDCS
Participants receive the stimulation with an intensity of 1.5 mA.
Intervention: 1.5 mA tDCS (Device)
Sham tDCS
Participants receive the sham stimulation (zero electric current after a short initial increase).
Intervention: Sham tDCS (Device)
Outcomes
Primary Outcomes
Change in the subjective rating of 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)
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.
Secondary Outcomes
- 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))
Investigators
Abed Hadipour Lakmehsari
Principal Investigator
University of Messina