Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Center for Veterans Research and Education | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS with cognitive training | Experimental | Participants will 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). |
|
| Sham tDCS with cognitive training | Sham Comparator | Participants will 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training | Device | Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change between baseline and 4 months post-stimulation (timepoint 8/final visit) |
| 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. | Change between baseline and 4 months post-stimulation (timepoint 8, final visit) |
| 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. | Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shalamar Sibley, MD, MPH | Minneapolis VAMC, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | United States |
Not provided
Recruitment/follow up completed with final participant's final visit (visit 8) on 6/26/20.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2018 |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
| Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training | Device | Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session). |
|
| Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit) |
| 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. |
| Baseline visit |
| FG001 | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
Two participants who were randomized to a group but did not start study intervention were included in this table.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Flanker Task Reaction Time | 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. | Mean | Standard Deviation | seconds |
| ||||||||||||||||
| Set Shifting Task Score | Description: The Set Shift Task Score is an ultimate composite score that is a summary score of reaction time and accuracy sub-scales. Scale range: Minimum 0, Maximum 10. Higher values represent a better outcome. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||||
| Unstructured Task Score | The Unstructured Task Score is the total sum of points awarded for completed puzzle items. Scale range: Minimum 0, Maximum 1469. Higher values represent a better outcome. The total score is a sum of scores for 3 individual trials. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||||
| Dot Counting Task Score | The Dot Count Task Score is the total sum of points awarded for dots a participant counts on the screen. Scale range: Minimum 0, Maximum 27. Higher values represent a better outcome. The total score is a sum of scores for 27 individual trials. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | pounds |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | Change between baseline and 4 months post-stimulation (timepoint 8/final visit) |
|
|
| ||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and 4 months post-stimulation (timepoint 8, final visit) |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit) |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit) |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | pounds | Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit) |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline visit |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | Baseline visit |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline visit |
|
Duration of treatment period (1 week)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG001 | 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). | 0 | 16 | 0 | 16 | 9 | 16 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
| ||
| Neck pain | General disorders | Systematic Assessment |
| ||
| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tingling | General disorders | Systematic Assessment |
| ||
| Itching | General disorders | Systematic Assessment |
| ||
| Burning sensation | General disorders | Systematic Assessment |
| ||
| Skin redness | General disorders | Systematic Assessment |
| ||
| Sleepiness/fatigue | General disorders | Systematic Assessment |
| ||
| Difficulty concentrating | General disorders | Systematic Assessment |
| ||
| Acute mood change | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
|
Our study was a pilot feasibility study.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalamar Sibley, MD, MPH | Minneapolis VA Medical Center | 612-467-1727 | Shalamar.Sibley@va.gov |
| Apr 18, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2018 | Jun 2, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D009765 | Obesity |
| D001070 | Appetitive Behavior |
| D000073599 | Health Risk Behaviors |
| D003192 | Compulsive Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
Participants will 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).
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|