Trial Outcomes & Findings for The Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Decreasing Food Cravings (NCT NCT01030289)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

before treatment, after treatment

Results posted on

2018-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Real tDCS 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Overall Study STARTED	9	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=19 Participants All participants enrolled in the study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	32.47 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Real tDCS n=9 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS n=10 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Food Cravings	-26.81 percentage of change in cravings Standard Deviation 26.11	-7.8 percentage of change in cravings Standard Deviation 41.87

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Real tDCS n=9 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS n=10 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Cravings for Sweet Foods	-30.5 percentage of change in cravings Standard Deviation 23.03	-0.95 percentage of change in cravings Standard Deviation 59.85

SECONDARY outcome

Timeframe: before treatment, during 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, 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.

Outcome measures

Outcome measures
Measure	Real tDCS n=9 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS n=10 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Cravings for Carbohydrate Foods before treatment to during treatment	-24.41 percentage of change in cravings Standard Deviation 41.67	22.10 percentage of change in cravings Standard Deviation 79.12
Cravings for Carbohydrate Foods before treatment to after treatment	-25.45 percentage of change in cravings Standard Deviation 45.6	14.87 percentage of change in cravings Standard Deviation 70.12

SECONDARY outcome

Timeframe: before treatment, during 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, 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.

Outcome measures

Outcome measures
Measure	Real tDCS n=9 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS n=10 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Inability to Resist Food and tDCS Condition before treatment to during treatment	26.79 percentage of change in resist ratings Standard Deviation 33.71	10.66 percentage of change in resist ratings Standard Deviation 39.57
Inability to Resist Food and tDCS Condition before treatment to after treatment	30.36 percentage of change in resist ratings Standard Deviation 30.82	13.38 percentage of change in resist ratings Standard Deviation 39.52

SECONDARY outcome

Timeframe: After treatment

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.

Outcome measures

Outcome measures
Measure	Real tDCS n=9 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS n=10 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Food Ingested and tDCS Condition Chocolate	2.7 percent change in grams of food ingested Standard Deviation 2.8	3.9 percent change in grams of food ingested Standard Deviation 6.4
Food Ingested and tDCS Condition Cookies	7.3 percent change in grams of food ingested Standard Deviation 12.7	7.2 percent change in grams of food ingested Standard Deviation 11.6
Food Ingested and tDCS Condition Potato Chips	6.7 percent change in grams of food ingested Standard Deviation 9.1	11.2 percent change in grams of food ingested Standard Deviation 14.0
Food Ingested and tDCS Condition Donuts	9.1 percent change in grams of food ingested Standard Deviation 16.8	7.0 percent change in grams of food ingested Standard Deviation 11.5

SECONDARY outcome

Timeframe: After treatment

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.

Outcome measures

Outcome measures
Measure	Real tDCS n=19 Participants 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive real tDCS.	Sham tDCS 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. Participant returns for the second visit 48-72 hours after completing the first visit to receive another session of sham tDCS.
Confidence Ratings in Guessing of Treatment Condition	6.45 units on a scale Standard Deviation 2.7	—

Adverse Events

Real tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Borckardt, Ph.D

Medical University of South Carolina

Phone: 843-792-3295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place