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

NCT ID: NCT01030289

Last Updated: 2018-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Craving

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

real tDCS First Visit

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.

Group Type ACTIVE_COMPARATOR

real tDCS

Intervention Type DEVICE

transcranial direct current stimulation

sham tDCS First Visit

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

transcranial direct current stimulation

real tDCS Second Visit

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.

Group Type ACTIVE_COMPARATOR

real tDCS

Intervention Type DEVICE

transcranial direct current stimulation

sham tDCS Second Visit

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

transcranial direct current stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

real tDCS

transcranial direct current stimulation

Intervention Type DEVICE

sham tDCS

transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 21-70 years of age

Exclusion Criteria

* 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
* metal implanted above the waist
* history of autoimmune or endocrine disorders
* diabetes
* allergy to latex
* allergy to peanuts
* brain tumors or lesions
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeffrey Borckardt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rachel Goldman, MA

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21352881 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Borckardt_19429

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.