Effect of tDCS Montage on Measures of Appetite

NCT03396549 | Completed

• 1 other identifier: IRB-300000049
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to validate a new sham (control) method for use in transcranial direct current stimulation (tDCS) that is less discernible to participants from the real condition. Participants are often able to tell real from sham conditions. Correctly guessing real from sham undermines the integrity of evaluations of the value of tDCS as a treatment tool as responses may be in part or entirely the result of treatment expectation effects. The study will test a new sham method to reduce food craving and eating and test how much participants are able to discern it from the real or 'target' condition.

Conditions

Eating Behavior

Keywords

tDCS; food craving; tDCS sham procedure; montage; food intake

Outcome Measures

Primary Outcomes (1)

• Eating Behaviors

  Amount of food eaten in kcals and food craving in ratings for degree of wanting a particular food displayed on computer screen.

  20 minutes

Secondary Outcomes (1)

• Detection of target from sham tDCS session.

  20 minutes

Study Arms (2)

real tDCS

EXPERIMENTAL

20 min of 2 mA tDCS over the right and left dorsolateral prefrontal cortex

Device: real tDCS

new sham tDCS

SHAM COMPARATOR

20 min 2 mA tDCS over the left and right sensorimotor cortex

Device: new sham tDCS

Interventions

new sham tDCS DEVICE

1 ch TCT transcranial stimulator

new sham tDCS

real tDCS DEVICE

1 ch TCT transcranial stimulator

real tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• UAB student
• Age 18-55

You may not qualify if:

• Implanted cranial metal plates or medical devices
• History of brain surgery
• Loss of consciousness \> 5 minutes
• Post-trauma amnesia lasting more than 30 minutes
• Diagnosis of schizophrenia, bipolar disorder, bulimia nervosa, anorexia nervosa, depression with suicidal intent or ideation
• Enrollment in a commercial weight-loss program
• Pregnancy or breastfeeding
• Uncontrolled diabetes or hypertension
• Current illicit drug use
• Intent to stop or begin use of a prescription drug or drugs that influence appetite
• Allergy to ingredients in the food that will be used in the eating test (e.g., wheat, gluten, soy, chocolate).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Mary M Boggiano, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the assistant delivering tDCS will not be blind to conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cross-over blind. All get sham and real tDCS.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 11, 2018
• Study Start: March 7, 2018
• Primary Completion: March 14, 2018
• Study Completion: March 14, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)