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Eating BehaviorNCT03396549

Effect of tDCS Montage on Measures of Appetite

A study testing real tDCS in people with Eating Behavior, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Eating Behavior
What is being tested?
real tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
7 Mar 2018to 14 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • UAB student
  • Age 18-55

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249

Other trials in United States

About this study

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.

Conditions
Eating Behavior
Being tested
new sham tDCS, real tDCS
Keywords
tDCS, food craving, tDCS sham procedure, montage, food intake
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • new sham tDCSDevice

    1 ch TCT transcranial stimulator

  • real tDCSDevice

    1 ch TCT transcranial stimulator

Study groups in NCT03396549
Study groupRoleWhat they receive
real tDCSExperimental20 min of 2 mA tDCS over the right and left dorsolateral prefrontal cortex
Receives: Device: real tDCS
new sham tDCSSham comparator20 min 2 mA tDCS over the left and right sensorimotor cortex
Receives: Device: new sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 minutes

Secondary outcomes (1)
  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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2018
  2. Study start7 Mar 2018
  3. Primary completion14 Mar 2018
  4. Study completion14 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Model description
Cross-over blind. All get sham and real tDCS.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396549
Sponsor's protocol ID
IRB-300000049
Status last verified
May 2018
First submitted
28 Dec 2017
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing real tDCS in people with Eating Behavior, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating Behaviors (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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