Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05225233

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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) * 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

Treatments and study arms

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)

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.

Primary outcomes

Change in task impulsivity as measured by the NIH FlankerChange between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

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 in weightChange between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

Differences in the magnitude of change in weights kilograms (kg) between active and sham tDCS (active from baseline to follow up sessions.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Minneapolis VA Health Care System, Minneapolis, MN🇺🇸 Minneapolis, Minnesota, United States
Shalamar D Sibley, MDContact
Shalamar D Sibley, MDPrincipal Investigator