NCT04405089

tDCS for Impulsivity and Compulsivity in Obesity

Completed NA Results posted Last updated 7 November 2023

What this trial tests

NA trial testing Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training in Impulsivity in 31 participants. Completed in 26 June 2020.

Timeline

3 May 2018

Primary endpoint
26 June 2020

26 June 2020

Quick facts

Lead sponsor	Minneapolis Veterans Affairs Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	3 May 2018
Primary completion	26 June 2020
Estimated completion	26 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
• Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Conditions studied

• Impulsivity — all drugs for Impulsivity →
• Compulsive Overeating — all drugs for Compulsive Overeating →
• Obesity — all drugs for Obesity →

Sponsor

Minneapolis Veterans Affairs Medical Center

Who can join

18 and older, any sex, with Impulsivity or Compulsive Overeating. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in NIH Examiner Flanker Task Reaction Time Primary · Change between baseline and 4 months post-stimulation (timepoint 8/final visit)

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.

Group	Value	95% CI
Active tDCS With Cognitive Training	-0.03	± 0.12
Sham tDCS With Cognitive Training	-0.12	± 0.22

Change in NIH Examiner Set Shifting Task Score Primary · Change between baseline and 4 months post-stimulation (timepoint 8, final visit)

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.

Group	Value	95% CI
Active tDCS With Cognitive Training	0.46	± 0.83
Sham tDCS With Cognitive Training	0.43	± 0.74

Change in NIH Examiner Dot Counting Task Score Primary · Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit)

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.

Group	Value	95% CI
Active tDCS With Cognitive Training	2.88	± 1.08
Sham tDCS With Cognitive Training	0.67	± 1.14

Change in NIH Examiner Unstructured Planning Task Score Primary · Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)

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.

Group	Value	95% CI
Active tDCS With Cognitive Training	64.25	± 41.38
Sham tDCS With Cognitive Training	41	± 26.49

Change in Weight Secondary · Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit)

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.

Group	Value	95% CI
Active tDCS With Cognitive Training	2.55	± 9.33
Sham tDCS With Cognitive Training	-6	± 10.14

Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior Secondary · Baseline visit

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 T

Group	Value	95% CI
Traumatic Brain Injury Positive (TBI+) Participants	17	± 8.46
Traumatic Brain Injury Negative (TBI-) Participants	14.94	± 8.46

Effect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker Secondary · 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

Group	Value	95% CI
Traumatic Brain Injury-Positive (TBI+) Participants	0.77	± 0.12
Traumatic Brain Injury-Negative (TBI-) Participants	0.93	± 0.2

Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting Secondary · 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 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.

Group	Value	95% CI
Traumatic Brain Injury Positive (TBI+) Participants	7.86	± 0.2
Traumatic Brain Injury Negative (TBI-) Participants	7.75	± 0.86

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of treatment period (1 week). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active tDCS With Cognitive Training

Serious: 0/13 (0%)

Deaths: 0/13

Sham tDCS With Cognitive Training

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (11 terms — click to expand)

Reaction	System	Active tDCS With Cognitive…	Sham tDCS With Cognitive T…
Itching	General disorders	—	—
Skin redness	General disorders	—	—
Sleepiness/fatigue	General disorders	—	—
Headache	General disorders	—	—
Tingling	General disorders	—	—
Burning sensation	General disorders	—	—
Difficulty concentrating	General disorders	—	—
Neck pain	General disorders	—	—
Acute mood change	General disorders	—	—
Scalp pain	Skin and subcutaneous tissue disorders	—	—
Nausea	General disorders	—	—

Data from ClinicalTrials.gov NCT04405089 adverse events section.

Sponsor's own description

Even when they know it can improve health, many individuals with loss of control eating struggle when they are trying to make and sustain new health habits for weight loss and maintenance of weight loss. Impulsivity, characterized by lack of foresight and planning and excessive risk taking, and compulsivity, characterized by inability to break old habitual behaviors, may play a role in refractory obesity. The primary objective of this pilot study is to investigate the effect of a novel neuroplasticity based intervention, cognitive training coupled with transcranial direct current stimulation (tDCS), on measures of impulsivity and compulsivity in individuals with obesity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.