tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sham Transcranial Direct Current Stimulation (tDCS), Active Transcranial Direct Current Stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial
Overview
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
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).
Interventions
- Device Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session) - Device Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Primary outcome measures
- Change in task impulsivity as measured by the NIH Flanker [Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)]
- Change in weight [Time frame: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)]
Secondary outcome measures (3)
- Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS) [Time frame: 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) [Time frame: 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) [Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)]
Eligibility criteria
Inclusion criteria
- Veteran enrolled in a MOVE! Weight Management Program (group or individual) at the Minneapolis VA Health Care System
- Obese (BMI>30 or BMI>27 plus at least one weight-related comorbidity)
- 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
- Acute substance dependence or withdrawal that would affect ability to complete cognitive training
- 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
- Uncontrolled hypothyroidism that would affect weight
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
Identifiers
NCT: NCT05225233 · NURA-009-21S