NCT01030289

Brief 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 immediately following the exposure to food stimuli.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

June 20, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

December 9, 2009

Results QC Date

March 29, 2016

Last Update Submit

June 15, 2018

Conditions

Keywords

food cravings

Outcome Measures

Primary Outcomes (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.

    before treatment, after treatment

Secondary Outcomes (5)

  • Cravings for Sweet Foods

    before treatment, after treatment

  • Cravings for Carbohydrate Foods

    before treatment, during treatment, after treatment

  • Inability to Resist Food and tDCS Condition

    before treatment, during treatment, after treatment

  • Food Ingested and tDCS Condition

    After treatment

  • Confidence Ratings in Guessing of Treatment Condition

    After treatment

Study Arms (4)

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.

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.

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.

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.

Device: sham tDCS

Interventions

real tDCSDEVICE

transcranial direct current stimulation

real tDCS First Visitreal tDCS Second Visit
sham tDCSDEVICE

transcranial direct current stimulation

sham tDCS First Visitsham tDCS Second Visit

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 21352881BACKGROUND

Related Links

Results Point of Contact

Title
Jeffrey Borckardt, Ph.D
Organization
Medical University of South Carolina

Study Officials

  • Rachel Goldman, MA

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 20, 2018

Results First Posted

June 20, 2018

Record last verified: 2018-06

Locations