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CompletedNCT03396549Updated May 15, 2018

Effect of tDCS Montage on Measures of Appetite

An interventional study of new sham tDCS and real tDCS in Eating Behavior, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

On Visit One:

N=30 college students will be given a unique assigned ID# to use on all electronic surveys. A Face Sheet will also record how hungry they feel at the time and will be rescheduled if overly hungry or full. Participants will then be measured for a BMI.

Participants will then complete an electronic survey that includes demographic questions including age, sex, ethnicity, handedness, and if they are vegan or vegetarian (to dismiss craving responses on animal-based foods on the food craving task). This is followed by an electronic battery of psychological questionnaires to assess eating motives, binge-eating, dietary restraint, impulsiveness, and suggestibility. Participants will then complete the Food Craving Task. They will do this immediately before and immediately after the tDCS session. Before the tDCS session participants will be shown a series of 24 colored images of appealing foods on the computer monitor and will be asked to rate how much they "like" the food and to measure craving: "how much they would like to eat the food right now if it were available" using a rating scale. After the tDCS session participants will be shown the same 24 photos and asked to rate them only for craving, not liking, as tDCS is not expected to change liking of foods. Liking ratings are taken so that only liked foods (rated a 2, 3, or 4 on the scale) are analyzed for their craving (wanting) scores. This avoids erroneous interpretation of decreased craving for the foods as being due to tDCS when the real reason is that they were not liked to begin with. Participants will then be escorted to the tDCS and eating room where they will then be seated in a comfortable chair facing a table a few yards away with three plates of food for the eating task. The researcher administering tDCS will instruct them to relax while she/he takes head measurements with a measuring tape. The measurements are taken according to the EEG 10-20 system to locate F3 and F4 which correspond to the left and right dorsolateral prefrontal cortex (DLPFC), or C3 and C4 which correspond to the left and right somatosensory/sensorimotor cortex (SSSM), depending on which montage they are receiving on the first visit. For the DLPFC, the anode will be placed over the right and cathode over the left DLPFC. For the SSSM, the anode will be placed over the left and cathode over the right SSSM. Two researchers will be present to facilitate the head measurements and confirm the accuracy of electrode placement. The locations are marked with a Sharpie marker on the scalp. The two 35 mm2 electrodes are covered in sponge sleeves with saline solution. These are placed over the marked locations and held by an adjustable head band. The researcher will turn on the device which will ramp up to 2 milliamps (mA) current in 30 seconds, hold at 2mA for 19 minutes them ramp down in the last 30 seconds for a total stimulation time of 20 minutes. During the session participants will be handed the Physical Sensations Scale (PSS) to rate sensation types and intensity for the first 5, 10, 15, and last minute of the session. The PSS is a modified version from Clark et al., 2012, and has been used successfully in Boggiano's previous tDCS studies. The modified PSS provides ratings that are more sensitive and individualized and will be submitted for publication consideration. They will know from reading the Consent Form and the PSS the possible sensations they may experience. The scale will be completed more times than the usual 1-2 times per session because it will be used to evaluate differences in sensations between the two tDCS montages. Low to no differences will indicate a good sham for the DLPFC montage. Immediately following the tDCS session, they will go back to the computer room to complete the post-tDCS part of the Food Craving Task as described above. After this, participants will be escorted back to the tDCS/eating room and will be given 15 minutes to consume the foods displayed on the table. The participants will then be escorted back to the computer room for a last Visit 1 Post-Eating Questionnaire. This is intended to obtain more information about any perceived changes in appetite or other functions following tDCS and compare them across the two montages.

On Visit Two:

As in Visit One, participants will then complete another pre-tDCS Food Craving Task with only the wanting questions as their liking of the foods on the photos is not expected to change. They will then receive the alternate tDCS montage as described for Visit One and complete the PSS four times during the session, followed by the post-tDCS Food Craving Task and another In-Lab Eating Task and "Visit 2 Post-Eating Questionnaire". This one will be exactly like the Visit 1 Post-Eating Questionnaire except that it will also ask participants to rank the 3 foods from most to least preferred in order to obtain the added measures of preferred-food eaten (mean of the #1-ranked food kcals) and less-preferred food eaten (mean of the average kcals between the #2- and #3-ranked foods). The researcher will then conduct a person-to-person omnibus interview with the Real vs. Sham Interview (RSI). This is designed to help validate the new sham method using the participants' perceptions of both sessions. The participants are then debriefed and compensated the participant.

02

Conditions studied

  • Eating Behavior

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Keywords

  • tDCS
  • food craving
  • tDCS sham procedure
  • montage
  • food intake
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 28 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • UAB student
  • Age 18-55

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    real tDCS

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

    Device: real tDCS

  • Sham comparator
    new sham tDCS

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

    Device: new sham tDCS

Interventions

  • Devicenew sham tDCS

    1 ch TCT transcranial stimulator

  • Devicereal tDCS

    1 ch TCT transcranial stimulator

06

What researchers measure

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.

    Time frame: 20 minutes

Secondary outcomes

  1. Detection of target from sham tDCS session.

    Difference between physical sensation ratings felt during the session and likert-like response ratings to an interview.

    Time frame: 20 minutes

07

Study locations

1 site
  • University of Alabama at Birmingham (UAB)
    Birmingham, Alabama 35249, United States
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 May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03396549
Responsible party
Mary Boggiano (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 11, 2018
Start date
Mar 7, 2018
Primary completion
Mar 14, 2018
Completion
Mar 14, 2018
Last update
May 15, 2018

Study contacts

Mary M Boggiano, PhD
principal investigator · University of Alabama at Birmingham

Oversight

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

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