Compulsive Overeating, Impulsivity, Obesity
Conditions
Keywords
Impulsive Behavior, Behavior Control, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior
Brief summary
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.
Detailed description
Impulsivity and compulsivity are two psychological factors which contribute to addictive behaviors. Impulsivity is characterized by lack of foresight and planning, and excessive risk taking. Impulsivity is a characteristic of poor executive functioning, and reflects deficits in goal-oriented behavior and self-regulation. Compulsivity is characterized by inability to break old habits. Both of these traits may play a role in refractory obesity. Transcranial direct current stimulation (tDCS) coupled with cognitive training may strengthen key circuitry involved in impulse control within the prefrontal cortex. tDCS coupled with cognitive training has the potential to reduce impulsivity and compulsivity in individuals with obesity, with the potential for therapeutic application as a non-pharmacologic approach to management of food-related eating behaviors which may impact weight. For this double-blind, randomized, placebo (sham) controlled study pilot study the investigators aim to recruit and complete studies in approximately 20 individuals, randomly assigned to receive either active or sham tDCS, both coupled with computerized cognitive training tasks, for five days. Additionally, participants will attend follow up visits at approximately 2, and 4 months after the course of intervention visits is completed. Testing pre- and post-intervention will include the Binge Eating Scale (BES), Patient Health Questionnaire 9 (PHQ-9) Depression Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the study. The Minnesota Blast Exposure Screening Tool (MN-BEST) is also conducted at baseline.
Interventions
Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Sponsors
Study design
Intervention model description
The study is not a disease treatment study. It involves of an Non-Significant Risk (NSR) device coupled with a set of computerized cognitive tasks in a small group of participants with primary outcome of change in an NIH Examiner domain (Flanker).
Eligibility
Inclusion criteria
* Obese (BMI\>30) * Adults ages 18 years or older receiving care through the Minneapolis VA Healthcare System * Able to understand English, self-consent and follow study-related procedures * Willing to use a reliable form of birth control if they are of females of child-bearing potential.
Exclusion criteria
* History of any of the following issues: seizures, severe or moderate head injury, head surgery, significant neurological disorder(significance based on Principal Investigator's judgment), frequent severe headaches * History of scalp conditions such as eczema or seborrheic dermatitis * Metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments * Implanted medical devices (including pumps and cardiac pacemakers) * Pregnancy * Active substance abuse * Psychological or medical disorders requiring inpatient treatment * Presence of a known metabolic or hormonal disorder (such as Cushing's) which affects weight/appetite. (History of hypothyroidism is acceptable if subject is on treatment with normal thyroid stimulating hormone (TSH) and free thyroxine (FT4) on most recent check within the last 3 months and has been on stable dosage of l-thyroxine for at least 3 months, taking it as prescribed.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NIH Examiner Flanker Task Reaction Time | 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. |
| Change in NIH Examiner Set Shifting Task Score | 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. |
| Change in NIH Examiner Dot Counting Task Score | 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. |
| Change in NIH Examiner Unstructured Planning Task Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 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. |
| Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior | 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 TBI-negative participants. |
Countries
United States
Participant flow
Recruitment details
Recruitment/follow up completed with final participant's final visit (visit 8) on 6/26/20.
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS With Cognitive Training 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. | 15 |
| Sham tDCS With Cognitive Training 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). | 16 |
| Total | 31 |
Baseline characteristics
| Characteristic | Active tDCS With Cognitive Training | Total | Sham tDCS With Cognitive Training |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 20 Participants | 9 Participants |
| Dot Counting Task Score | 14.64 score on a scale STANDARD_DEVIATION 4.41 | 14.97 score on a scale STANDARD_DEVIATION 4.25 | 15.25 score on a scale STANDARD_DEVIATION 4.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Flanker Task Reaction Time | 0.86 seconds STANDARD_DEVIATION 0.17 | 0.88 seconds STANDARD_DEVIATION 0.19 | 0.89 seconds STANDARD_DEVIATION 0.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 25 Participants | 13 Participants |
| Set Shifting Task Score | 7.73 score on a scale STANDARD_DEVIATION 0.93 | 7.69 score on a scale STANDARD_DEVIATION 0.83 | 7.65 score on a scale STANDARD_DEVIATION 0.76 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 Participants |
| Unstructured Task Score | 336.07 score on a scale STANDARD_DEVIATION 66.11 | 332 score on a scale STANDARD_DEVIATION 79.17 | 328.44 score on a scale STANDARD_DEVIATION 91.11 |
| Weight | 260.76 pounds STANDARD_DEVIATION 59.33 | 256.06 pounds STANDARD_DEVIATION 51.19 | 251.95 pounds STANDARD_DEVIATION 44.46 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 10 / 13 | 9 / 16 |
| serious Total, serious adverse events | 0 / 13 | 0 / 16 |
Outcome results
Change in NIH Examiner Dot Counting Task Score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Change in NIH Examiner Dot Counting Task Score | 2.88 score on a scale | Standard Deviation 1.08 |
| Sham tDCS With Cognitive Training | Change in NIH Examiner Dot Counting Task Score | 0.67 score on a scale | Standard Deviation 1.14 |
Change in NIH Examiner Flanker Task Reaction Time
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Change in NIH Examiner Flanker Task Reaction Time | -0.03 seconds | Standard Deviation 0.12 |
| Sham tDCS With Cognitive Training | Change in NIH Examiner Flanker Task Reaction Time | -0.12 seconds | Standard Deviation 0.22 |
Change in NIH Examiner Set Shifting Task Score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Change in NIH Examiner Set Shifting Task Score | 0.46 score on a scale | Standard Deviation 0.83 |
| Sham tDCS With Cognitive Training | Change in NIH Examiner Set Shifting Task Score | 0.43 score on a scale | Standard Deviation 0.74 |
Change in NIH Examiner Unstructured Planning Task Score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Change in NIH Examiner Unstructured Planning Task Score | 64.25 score on a scale | Standard Deviation 41.38 |
| Sham tDCS With Cognitive Training | Change in NIH Examiner Unstructured Planning Task Score | 41 score on a scale | Standard Deviation 26.49 |
Change in Weight
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Change in Weight | 2.55 pounds | Standard Deviation 9.33 |
| Sham tDCS With Cognitive Training | Change in Weight | -6 pounds | Standard Deviation 10.14 |
Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior | 17 score on a scale | Standard Deviation 8.46 |
| Sham tDCS With Cognitive Training | Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior | 14.94 score on a scale | Standard Deviation 8.46 |
Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | 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 |
| Sham tDCS With Cognitive Training | Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting | 7.75 score on a scale | Standard Deviation 0.86 |
Effect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker
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.
Time frame: 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 post-hoc analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS With Cognitive Training | Effect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker | 0.77 seconds | Standard Deviation 0.12 |
| Sham tDCS With Cognitive Training | Effect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker | 0.93 seconds | Standard Deviation 0.2 |