tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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Two-hundred forty individuals will be screened with the goal of consenting and enrolling 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).

Official Title
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Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial

Conditions
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Obesity

Intervention / Treatment
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* Device: Sham Transcranial Direct Current Stimulation (tDCS)
* Device: Active Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran enrolled in the MOVE! Weight Management Program at the Minneapolis VA Health Care System Obese (BMI>30) Adults, ages 18 years or older (up to age 80) 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: 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 Moderately severe to severe depression (as identified on PHQ-9 scale during baseline screening) Other psychological or medical disorders requiring inpatient treatment (as identified during chart review) Presence of a known metabolic or hormonal disorder (such as Cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin A1c > 8.0), or significant edema/volume overload - all of which would affect weight History of hypothyroidism is acceptable if subject is on treatment with normal thyroid stimulating hormone (TSH) and 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS with Cognitive Training<br>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. | Device: Active Transcranial Direct Current Stimulation (tDCS)<br>* Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.<br>|
| Sham Comparator: Sham tDCS with Cognitive Training<br>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. | Device: Sham Transcranial Direct Current Stimulation (tDCS)<br>* Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, neuromodulation