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tDCS for Impulsivity and Compulsivity in Obesity

Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04405089
Enrollment
31
Registered
2020-05-28
Start date
2018-05-03
Completion date
2020-06-26
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compulsive Overeating, Impulsivity, Obesity

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

DEVICEDevice: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.

DEVICEDevice: 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).

Sponsors

Center for Veterans Research and Education
CollaboratorOTHER
Minneapolis Veterans Affairs Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in NIH Examiner Flanker Task Reaction TimeChange 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 ScoreChange 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 ScoreChange 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 ScoreChange 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

MeasureTime frameDescription
Change in WeightChange 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 BehaviorBaseline visitEffect 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

ArmCount
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
Total31

Baseline characteristics

CharacteristicActive tDCS With Cognitive TrainingTotalSham tDCS With Cognitive Training
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants11 Participants7 Participants
Age, Categorical
Between 18 and 65 years
11 Participants20 Participants9 Participants
Dot Counting Task Score14.64 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 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants30 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Flanker Task Reaction Time0.86 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 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
12 Participants25 Participants13 Participants
Set Shifting Task Score7.73 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 Participants10 Participants4 Participants
Sex: Female, Male
Male
9 Participants21 Participants12 Participants
Unstructured Task Score336.07 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
Weight260.76 pounds
STANDARD_DEVIATION 59.33
256.06 pounds
STANDARD_DEVIATION 51.19
251.95 pounds
STANDARD_DEVIATION 44.46

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 16
other
Total, other adverse events
10 / 139 / 16
serious
Total, serious adverse events
0 / 130 / 16

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingChange in NIH Examiner Dot Counting Task Score2.88 score on a scaleStandard Deviation 1.08
Sham tDCS With Cognitive TrainingChange in NIH Examiner Dot Counting Task Score0.67 score on a scaleStandard Deviation 1.14
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingChange in NIH Examiner Flanker Task Reaction Time-0.03 secondsStandard Deviation 0.12
Sham tDCS With Cognitive TrainingChange in NIH Examiner Flanker Task Reaction Time-0.12 secondsStandard Deviation 0.22
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingChange in NIH Examiner Set Shifting Task Score0.46 score on a scaleStandard Deviation 0.83
Sham tDCS With Cognitive TrainingChange in NIH Examiner Set Shifting Task Score0.43 score on a scaleStandard Deviation 0.74
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingChange in NIH Examiner Unstructured Planning Task Score64.25 score on a scaleStandard Deviation 41.38
Sham tDCS With Cognitive TrainingChange in NIH Examiner Unstructured Planning Task Score41 score on a scaleStandard Deviation 26.49
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingChange in Weight2.55 poundsStandard Deviation 9.33
Sham tDCS With Cognitive TrainingChange in Weight-6 poundsStandard Deviation 10.14
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior17 score on a scaleStandard Deviation 8.46
Sham tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior14.94 score on a scaleStandard Deviation 8.46
Comparison: Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).
Post Hoc

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting7.86 score on a scaleStandard Deviation 0.2
Sham tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior-NIH Set Shifting7.75 score on a scaleStandard Deviation 0.86
Comparison: Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).
Post Hoc

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.

ArmMeasureValue (MEAN)Dispersion
Active tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker0.77 secondsStandard Deviation 0.12
Sham tDCS With Cognitive TrainingEffect of History of Traumatic Brain Injury on Impulsive Behavior - NIH Flanker0.93 secondsStandard Deviation 0.2
Comparison: Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026