Trial Outcomes & Findings for tDCS for Impulsivity and Compulsivity in Obesity (NCT NCT04405089)

Last Updated: 2023-11-07

Results Overview

Differences in change in Flanker Task reaction time (score at final follow-up visit minus score at baseline) between active tDCS-cognitive training and sham-cognitive training groups. NIH Flanker absolute value range: 0 to 5 seconds. Higher values represent a better outcome. In the Flanker Task, a participant is instructed to press a key in response to viewing a stimulus presented on-screen. The Reaction Time, or the amount of time in seconds between presentation of the stimulus and the response, is measured.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Change between baseline and 4 months post-stimulation (timepoint 8/final visit)

Results posted on

2023-11-07

Participant Flow

Recruitment/follow up completed with final participant's final visit (visit 8) on 6/26/20.

Participant milestones

Participant milestones
Measure	Active tDCS With Cognitive Training Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 milliamperes (mAmps) for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Overall Study STARTED	15	16
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

tDCS for Impulsivity and Compulsivity in Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS With Cognitive Training n=15 Participants Participants receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=16 Participants Participants receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Flanker Task Reaction Time	0.86 seconds STANDARD_DEVIATION 0.17 • n=5 Participants	0.89 seconds STANDARD_DEVIATION 0.21 • n=7 Participants	0.88 seconds STANDARD_DEVIATION 0.19 • n=5 Participants
Set Shifting Task Score	7.73 score on a scale STANDARD_DEVIATION 0.93 • n=5 Participants	7.65 score on a scale STANDARD_DEVIATION 0.76 • n=7 Participants	7.69 score on a scale STANDARD_DEVIATION 0.83 • n=5 Participants
Unstructured Task Score	336.07 score on a scale STANDARD_DEVIATION 66.11 • n=5 Participants	328.44 score on a scale STANDARD_DEVIATION 91.11 • n=7 Participants	332 score on a scale STANDARD_DEVIATION 79.17 • n=5 Participants
Dot Counting Task Score	14.64 score on a scale STANDARD_DEVIATION 4.41 • n=5 Participants	15.25 score on a scale STANDARD_DEVIATION 4.23 • n=7 Participants	14.97 score on a scale STANDARD_DEVIATION 4.25 • n=5 Participants
Weight	260.76 pounds STANDARD_DEVIATION 59.33 • n=5 Participants	251.95 pounds STANDARD_DEVIATION 44.46 • n=7 Participants	256.06 pounds STANDARD_DEVIATION 51.19 • n=5 Participants

PRIMARY outcome

Timeframe: Change between baseline and 4 months post-stimulation (timepoint 8/final visit)

Population: Due to the Coronavirus (COVID-19) pandemic preventing in-person data collection of task data, the N for this measure is lower than the baseline N.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=9 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Change in NIH Examiner Flanker Task Reaction Time	-0.03 seconds Standard Deviation 0.12	-0.12 seconds Standard Deviation 0.22

PRIMARY outcome

Timeframe: Change between baseline and 4 months post-stimulation (timepoint 8, final visit)

Population: Due to the Coronavirus (COVID-19) pandemic preventing in-person data collection of task data, the N for this measure is lower than the baseline N.

Difference in change in Set Shifting Task scores (score at final visit minus baseline score) between active tDCS-cognitive training and sham- Higher values represent a better outcome. Set Shifting Scale absolute value range: Minimum -10, Maximum 10. The Set Shifting Task Score is a combination of two subscores for reaction time and accuracy on the task.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=9 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Change in NIH Examiner Set Shifting Task Score	0.46 score on a scale Standard Deviation 0.83	0.43 score on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit)

Population: Due to the Coronavirus (COVID-19) pandemic preventing in-person data collection of task data, the N for this measure is lower than the baseline N.

Differences in change in NIH Examiner Dot Counting Task scores (i.e., score at final visit minus baseline score) between active tDCS-cognitive training and sham-cognitive training groups. The change in score is equal to the score taken at the final follow-up visit minus the score taken at baseline. NIH Dot Counting absolute value range: numerical value -27 to +27. Higher values represent a better outcome. The Dot Count Task Score is the total sum of points awarded for dots a participant counts on the screen. The total score is a sum of scores for 27 individual trials.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=9 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Change in NIH Examiner Dot Counting Task Score	2.88 score on a scale Standard Deviation 1.08	0.67 score on a scale Standard Deviation 1.14

PRIMARY outcome

Timeframe: Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)

Population: Due to the Coronavirus (COVID-19) pandemic preventing in-person data collection of task data, the N for this measure is lower than the baseline N.

Differences in change in NIH Examiner Unstructured Planning Task scores (i.e., score at final visit minus baseline score) between active tDCS-cognitive training and sham-cognitive training groups. The change in score is equal to the score taken at the final follow-up visit minus the score taken at baseline. Higher values represent a better outcome. The Unstructured Task Score is a numeric summary score that is equal to the total sum of points awarded for completed puzzle items. The total absolute score is a sum of scores for 3 individual trials, Absolute score range :-1469 to +1469.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=9 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Change in NIH Examiner Unstructured Planning Task Score	64.25 score on a scale Standard Deviation 41.38	41 score on a scale Standard Deviation 26.49

SECONDARY outcome

Timeframe: Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit)

Population: Due to the Coronavirus (COVID-19) pandemic preventing in-person data collection of task data, the N for this measure is lower than the baseline N. One additional subject was excluded from the weight analysis due to participation in a commercial weight-loss program during the study.

Difference in change in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups (i.e., end of study weight minus baseline weight). A more negative score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=8 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Change in Weight	2.55 pounds Standard Deviation 9.33	-6 pounds Standard Deviation 10.14

SECONDARY outcome

Timeframe: Baseline visit

Population: Analysis was pre-specified at baseline to be reported by TBI status. Eight baseline participants did not complete the Minnesota Blast Exposure Screening Tool and were not included in this secondary analysis.

Effect of history of a traumatic brain injury (TBI) on impulsive/compulsive eating behavior. A status of either TBI+ (positive for history of TBI) or TBI- (negative for history of TBI) was determined at the baseline visit with the Minnesota Blast Exposure Screening Tool. Impulsive/compulsive eating behavior was defined as the score on the Binge Eating Scale (BES) taken at the baseline visit. Scale range = 0-48. Lower scores indicate less impulsive/compulsive eating behavior (i.e., a better outcome). Calculation details: Average BES scores taken at baseline for TBI-positive participants and TBI-negative participants.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=6 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=17 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior	17 score on a scale Standard Deviation 8.46	14.94 score on a scale Standard Deviation 8.46

POST_HOC outcome

Timeframe: Baseline visit

Effect of history of a traumatic brain injury (TBI) on impulsive behavior. A status of either TBI+ (positive for history of TBI) or TBI- (negative for history of TBI) was determined at baseline with the Minnesota Blast Exposure Screening Tool. Impulsive behavior was defined as the score on the Flanker task measured at the baseline visit. The Flanker score is equal to the average reaction time, in seconds, to respond to trials. Minimum = 0, maximum = 2. A higher score indicates less-impulsive behavior (i.e., a better outcome). Calculation details: Flanker scores for TBI-positive participants and TBI-negative participants.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=6 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=17 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Effect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker	0.77 seconds Standard Deviation 0.12	0.93 seconds Standard Deviation 0.2

POST_HOC outcome

Timeframe: Baseline visit

Population: Eight baseline participants did not complete the Minnesota Blast Exposure Screening Tool and were not included in this post-hoc analysis. Analysis was pre-specified at baseline to be reported by TBI status.

Effect of history of a traumatic brain injury (TBI) on impulsive behavior. A status of either TBI+ (positive for history of TBI) or TBI- (negative for history of TBI) was determined at baseline with the Minnesota Blast Exposure Screening Tool. Impulsive behavior was defined as the NIH Set Shifting score measured at baseline. Score range: 0 - 10. Higher scores indicate less impulsive behavior (i.e. a better outcome). Calculation details: Set Shifting scores for TBI-positive participants and TBI-negative participants.

Outcome measures

Outcome measures
Measure	Active tDCS With Cognitive Training n=6 Participants Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=17 Participants Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting	7.86 score on a scale Standard Deviation 0.2	7.75 score on a scale Standard Deviation 0.86

Adverse Events

Active tDCS With Cognitive Training

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Sham tDCS With Cognitive Training

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active tDCS With Cognitive Training n=13 participants at risk Participants received 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes). Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.	Sham tDCS With Cognitive Training n=16 participants at risk Participants received 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
General disorders Headache	30.8% 4/13 • Number of events 10 • Duration of treatment period (1 week)	6.2% 1/16 • Number of events 1 • Duration of treatment period (1 week)
General disorders Neck pain	15.4% 2/13 • Number of events 3 • Duration of treatment period (1 week)	6.2% 1/16 • Number of events 1 • Duration of treatment period (1 week)
Skin and subcutaneous tissue disorders Scalp pain	7.7% 1/13 • Number of events 3 • Duration of treatment period (1 week)	6.2% 1/16 • Number of events 1 • Duration of treatment period (1 week)
General disorders Tingling	30.8% 4/13 • Number of events 4 • Duration of treatment period (1 week)	12.5% 2/16 • Number of events 3 • Duration of treatment period (1 week)
General disorders Itching	53.8% 7/13 • Number of events 14 • Duration of treatment period (1 week)	12.5% 2/16 • Number of events 2 • Duration of treatment period (1 week)
General disorders Burning sensation	23.1% 3/13 • Number of events 4 • Duration of treatment period (1 week)	6.2% 1/16 • Number of events 1 • Duration of treatment period (1 week)
General disorders Skin redness	46.2% 6/13 • Number of events 11 • Duration of treatment period (1 week)	0.00% 0/16 • Duration of treatment period (1 week)
General disorders Sleepiness/fatigue	38.5% 5/13 • Number of events 13 • Duration of treatment period (1 week)	25.0% 4/16 • Number of events 8 • Duration of treatment period (1 week)
General disorders Difficulty concentrating	15.4% 2/13 • Number of events 4 • Duration of treatment period (1 week)	18.8% 3/16 • Number of events 7 • Duration of treatment period (1 week)
General disorders Acute mood change	7.7% 1/13 • Number of events 1 • Duration of treatment period (1 week)	12.5% 2/16 • Number of events 3 • Duration of treatment period (1 week)
General disorders Nausea	0.00% 0/13 • Duration of treatment period (1 week)	0.00% 0/16 • Duration of treatment period (1 week)

Additional Information

Dr. Shalamar Sibley, MD, MPH

Minneapolis VA Medical Center

Phone: 612-467-1727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place