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CravingNCT01030289

The Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Decreasing Food Cravings

A study testing real tDCS in people with Craving, run by Medical University of South Carolina 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

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in decreasing food cravings. Specifically, this study will determine whether healthy subjects will report decreased food craving following a single 20-minute session of tDCS (compared to sham tDCS) delivered during and… Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Craving
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
19 participants
Where
1 siteUnited States
Study dates
Oct 2009to Nov 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 21-70 years of age

Who cannot join

  • pregnant
  • history of seizures or epilepsy
  • family history or seizures
  • history of eating disorder
  • history of depression
  • taking medications that have been shown to lower seizure threshold
Show all 12Show fewer
  • metal implanted above the waist
  • history of autoimmune or endocrine disorders
  • diabetes
  • allergy to latex
  • allergy to peanuts
  • brain tumors or lesions

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brain Stimulation Laboratory, Institute of Psychiatry

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: The Effectiveness of tDCS in Decreasing Food Cravings

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in decreasing food cravings. Specifically, this study will determine whether healthy subjects will report decreased food craving following a single 20-minute session of tDCS (compared to sham tDCS) delivered during and immediately following the exposure to food stimuli.

Read the detailed description

Recently, the use of low amplitude direct current stimulation of the human cortex has received attention as a possible for treatment for depression and pain (Been et al, 2007). This technique (called transcranial direct current stimulation or tDCS) involves the placement of two sponge electrodes over separate areas of the scalp. tDCS has been shown to be capable of changing the excitability of the superficial neurons immediately beneath the sponge electrodes. Evidence suggests that anodal stimulation is associated with increased cortical excitability and cathodal stimulation is associated with decreased cortical excitability (Been et al, 2007).

Brain imaging studies are beginning to elucidate the functional neuroanatomy of cravings (George, Anton, Bloomer, Teneback, Drobes, Lorberbaum, et al., 2001; Myrick, Anton, Li, Henderson, Drobes, Voronin, et al., 2004). While the role of the prefrontal cortex in regulating cravings remains somewhat unclear, frontal cortical areas appear to be involved in integrating incoming sensory information (such as sights, smells, and sounds) with affective/emotional information in the brain, and may be involved in regulating emotional reactions to various stimuli (Alexander, DeLong, \& Strick, 1986; Lorenz, Minoshima, \& Casey, 2003). The dorsal lateral prefrontal cortex may become activated when an individual is presented with cues that trigger reward memories associated with certain consumptive behaviors (Anton, 1999). One fMRI study found that when alcoholic subjects were presented with alcohol related cues, there was greater activation in the left prefrontal cortex and anterior thalamus, compared to when they viewed non-alcohol cues (George et al., 2001). Other studies on bulimia and drug cravings have identified hyperactivity in the orbitofrontal cortex and anterior cingulate cortex associated with increases in cravings ratings (Goldstein \& Volkow, 2002; Uher, et al., 2004).

Very few studies have attempted to directly manipulate activation of brain structures that might be involved in cravings. tDCS allows researchers to selectively activate or inhibit different brain structures that might play a role in craving behaviors. Previous research with manipulating the activation of brain structures found that alcohol cravings decreased among individuals with alcohol dependence who received either left or right anodal stimulation of the dorsolateral prefrontal cortex (Boggio et al., 2008). This finding, combined with prior functional neuroanatomical work, and research on the relation of food cravings and nicotine cravings suggesting they share a common biologic mechanism (Pepino, Finkbiener, Menella 2009, 2007), suggests that the prefrontal cortex may be a reasonable preliminary tDCS cortical target for potentially inhibiting food cravings.

To date, there has only been one published study examining the relationship between tDCS and food craving. Fregni and colleagues (2008) found cravings to be reduced by anode right/cathode left tDCS and cravings did not increase after anode left/cathode right tDCS. The evidence on the effectiveness of tDCS for decreasing food craving indicates relatively short-lived effects (lasting only a few weeks). While this may ultimately limit the utility of tDCS, it may have a place in the prevention and management of obesity.

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in decreasing food cravings. Specifically, this study will determine whether healthy subjects will report decreased food craving following a single 20-minute session of tDCS (compared to sham tDCS) delivered during and immediately following the exposure to food stimuli.

Conditions
Craving
Being tested
real tDCS, sham tDCS
Keywords
food cravings

What participants receive

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

  • real tDCSDevice

    transcranial direct current stimulation

  • sham tDCSDevice

    transcranial direct current stimulation

Study groups in NCT01030289
Study groupRoleWhat they receive
real tDCS First VisitActive comparatorOn the First Visit, A single 20-minute tDCS session will be conducted using 2.0mA current. Using the international 10-20 EEG system, the anode will be placed over F4, which corresponds to the right dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over F3, which corresponds to the left dorsolateral prefrontal cortex. Electrodes will be standard sponge electrodes soaked In a sterile solution of .9% sodium chloride insulated by a latex casing.
Receives: Device: real tDCS
sham tDCS First VisitSham comparatorOn the First Visit, For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
Receives: Device: sham tDCS
real tDCS Second VisitActive comparatorParticipant returns for the second visit 48-72 hours after completing the first visit. A single 20-minute tDCS session will be conducted using 2.0mA current. Using the international 10-20 EEG system, the anode will be placed over F4, which corresponds to the right dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over F3, which corresponds to the left dorsolateral prefrontal cortex. Electrodes will be standard sponge electrodes soaked In a sterile solution of .9% sodium chloride insulated by a latex casing.
Receives: Device: real tDCS
sham tDCS Second VisitSham comparatorParticipant returns for the second visit 48-72 hours after completing the first visit. For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
Receives: Device: sham tDCS

What is being measured

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

  1. Food Cravings

    Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).

    The before treatment after treatment food craving ratings were used to calculate percent change.

    Measured: before treatment, after treatment

Secondary outcomes (5)
  1. Cravings for Sweet Foods

    Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no sweet food cravings) to 100 (extreme sweet food cravings).

    The before treatment after treatment ratings for sweet food craving were used to calculate percent change.

    Measured: before treatment, after treatment

  2. Cravings for Carbohydrate Foods

    Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).

    The before treatment, during treatment, and after treatment ratings for carbohydrates were used to calculate percent change.

    Measured: before treatment, during treatment, after treatment

  3. Inability to Resist Food and tDCS Condition

    Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings, completely resist food) to 100 (extreme food cravings, unable to resist food).

    The before treatment, during treatment, and after treatment resist ratings for carbohydrates were used to calculate percent change.

    Measured: before treatment, during treatment, after treatment

  4. Food Ingested and tDCS Condition

    Food was presented on a plate for the participants to eat after treatment. Each participant received a Chocolate Plate, Donut Plate, Cookie Plate, and a Potatoe Chip Plate. Each participant received the same amount of food on each plate. Each plate was weighed in grams separately before and after eating the food. A difference score was calculated to determine how much food was eaten for each type of food.

    The mean difference score was calculated for each type of food for the Sham tDCS group \& the Real tDCS group. The means and standard deviations of percent change in the decrease of food (weighed in grams) ingested post-tDCS treatment are reported below for the real tDCS group and the sham tDCS group.

    Measured: After treatment

  5. Confidence Ratings in Guessing of Treatment Condition

    At the end of the participants' second appointment, they were asked to guess which tDCS session was real and which was sham. 0=completely guessing. 10=absolutely sure. We calculated how many participants correctly guessed when they received real and when they received sham. A composite index was created to control for correct-guessing in the mixed model analysis. A new variable was created wherein the "guess correct" value (0=incorrect guess, 1=correct guess) was multiplied by the guess confidence rating for each participant. Thus, those that guess incorrectly had a guess-composite value of 0 whereas those that guessed correctly had a value equal to their guess confidence.

    Measured: After treatment

Timeline

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

  1. First posted11 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01030289
Sponsor's protocol ID
Borckardt_19429
Status last verified
Jun 2018
First submitted
9 Dec 2009
Last updated
20 Jun 2018
Data monitoring committee
No

Publications

  • Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.

    PubMed 21352881

Questions about this trial

What is this clinical trial studying?

A study testing real tDCS in people with Craving, run by Medical University of South Carolina 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 1 inclusion and 12 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 20 Jun 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?

Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Food Cravings (time frame: before treatment, after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01030289, which also lists 1 linked publication.

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 20 Jun 2018.

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