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.
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
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 group | Role | What they receive |
|---|---|---|
| real tDCS | Experimental | 20 min of 2 mA tDCS over the right and left dorsolateral prefrontal cortex Receives: Device: real tDCS |
| new sham tDCS | Sham comparator | 20 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.
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)
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.
- First posted11 Jan 2018
- Study start7 Mar 2018
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Boggiano, University of Alabama at Birmingham
- Investigators
- Mary M Boggiano, PhD, Principal investigator, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of tDCS Montage on Measures of Appetite
- ClinicalTrials.gov ID
- NCT03396549
- Acronym / sponsor ID
- IRB-300000049
- Conditions
- Eating Behavior
- Keywords
- tDCS, food craving, tDCS sham procedure, montage, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-over blind. All get sham and real tDCS.
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Experimental | Device: real tDCS20 min of 2 mA tDCS over the right and left dorsolateral prefrontal cortex |
| new sham tDCS | Sham comparator | Device: new sham tDCS20 min 2 mA tDCS over the left and right sensorimotor cortex |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- UAB student
- Age 18-55
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new sham tDCS1 ch TCT transcranial stimulator | Device | new sham tDCS |
| real tDCS1 ch TCT transcranial stimulator | Device | real tDCS |
Primary outcome
Eating Behaviors
Time frame: 20 minutes
Amount of food eaten in kcals and food craving in ratings for degree of wanting a particular food displayed on computer screen.
1 secondary outcome
Detection of target from sham tDCS session.
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M Boggiano, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
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.