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The purpose of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to reduce impulsivity in individuals with obesity, and to evaluate weight change with these individuals. The long-term goal of this research is to develop new treatment approaches for individuals with obesity.
Two-hundred forty individuals will be screened with the goal of consenting and enrolling up to 124 patients and 88 patients completing the study. Participants completing the study will concurrently complete a structured weight loss program. The investigators' study protocol will consist of 13 study visits including four testing days, one before (V1), one on the day of the tenth session of tDCS (V11), another test visit (V12) 6 weeks later, and a final test visit approximately 4 months after beginning stimulation (V13).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS with Cognitive Training | Experimental | Participants will receive active tDCS stimulation with their cognitive training during a one-hour session each day which includes 20 minutes of stimulation at the beginning of a 46-minute task training session. Ten sessions will be completed over three weeks. |
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| Sham tDCS with Cognitive Training | Sham Comparator | Participants will receive 10 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 seconds, 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in task impulsivity as measured by the NIH Flanker | Differences in the magnitude of change in NIH Flanker Reaction Time (RT) (ms) between active and sham groups from baseline to follow up sessions. | Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) |
| Change in weight | Differences in the magnitude of change in weights (kg) between active and sham tDCS (active from baseline to follow up sessions. | Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS) | Differences in the magnitude of change in BIS scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions. | Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shalamar D Sibley, MD | Contact | (612) 725-2000 | 4424 | Shalamar.Sibley@va.gov |
| Lisa E Keacher, BS | Contact | (612) 467-5203 | lisa.keacher@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Shalamar D Sibley, MD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Recruiting | Minneapolis | Minnesota | 55417-2309 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Active Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes. |
|
| Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P) | Differences in the magnitude of change in UPPS-P scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions. | Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) |
| Change in reported binge eating as measured by the Binge Eating Scale (BES) | Differences in the magnitude of change in BES scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions. | Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |