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.
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
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 group | Role | What they receive |
|---|---|---|
| real tDCS First Visit | Active comparator | On 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 Visit | Sham comparator | On 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 Visit | Active comparator | Participant 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 Visit | Sham comparator | Participant 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.
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)
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
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
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
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
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.
- First posted11 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CravingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Borckardt, Medical University of South Carolina
- Investigators
- Rachel Goldman, MA, Principal investigator, Medical University of South Carolina
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of tDCS in Decreasing Food Cravings
- ClinicalTrials.gov ID
- NCT01030289
- Acronym / sponsor ID
- Borckardt_19429
- Conditions
- Craving
- Keywords
- food cravings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 20 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| real tDCS First Visit | Active comparator | Device: real tDCSOn 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. |
| sham tDCS First Visit | Sham comparator | Device: sham tDCSOn 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. |
| real tDCS Second Visit | Active comparator | Device: real tDCSParticipant 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. |
| sham tDCS Second Visit | Sham comparator | Device: sham tDCSParticipant 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 21-70 years of age
Key exclusion criteria (12 listed)
- pregnant
- history of seizures or epilepsy
- family history or seizures
- history of eating disorder
- history of depression
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 |
|---|---|---|
| real tDCStranscranial direct current stimulation | Device | real tDCS First Visit, real tDCS Second Visit |
| sham tDCStranscranial direct current stimulation | Device | sham tDCS First Visit, sham tDCS Second Visit |
Primary outcome
Food Cravings
Time frame: before treatment, after treatment
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.
5 secondary outcomes
Cravings for Sweet Foods
Time frame: before treatment, after treatment
Cravings for Carbohydrate Foods
Time frame: before treatment, during treatment, after treatment
Inability to Resist Food and tDCS Condition
Time frame: before treatment, during treatment, after treatment
Food Ingested and tDCS Condition
Time frame: After treatment
Confidence Ratings in Guessing of Treatment Condition
Time frame: After treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21352881Goldman 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.
- Link to Published ResultsLink provided by the sponsor.
Related trials for Craving
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
RecruitingPhase 1
Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30)
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruiting
Closed-loop TMS for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
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.
Rachel Goldman, MA principal investigator
Medical University of South Carolina
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 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.