Using brain stimulation and cognitive training to help veterans with obesity
Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial
NA · VA Office of Research and Development · NCT05225233
This study is testing whether using brain stimulation along with mental training can help veterans with obesity lose weight and control their impulsive eating.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05225233 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcranial direct current stimulation (tDCS) combined with cognitive training to reduce impulsivity and promote weight loss in veterans with obesity. A total of 240 individuals will be screened, aiming to enroll 124 participants who will undergo a structured weight loss program alongside the tDCS intervention. The study includes 13 visits over several months, with assessments conducted before, during, and after the treatment to evaluate changes in weight and impulsivity. The ultimate goal is to develop innovative treatment strategies for obesity in this population.
Who should consider this trial
Good fit: Ideal candidates are veterans enrolled in a weight management program who are obese and aged 18 to 80.
Not a fit: Patients with a history of neurological disorders, severe headaches, or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide veterans with obesity a new method to manage their weight and impulsivity effectively.
How similar studies have performed: While the use of tDCS in obesity treatment is still emerging, similar neuromodulation approaches have shown promise in other areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Shalamar D Sibley, MD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Shalamar D Sibley, MD
- Email: Shalamar.Sibley@va.gov
- Phone: (612) 725-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, transcranial direct current stimulation, neuromodulation