Clinical trial NCT05225233: tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity
Official title: Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: transcranial direct current stimulation
neuromodulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-02-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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).

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

Primary outcomes:
measure: Change in task impulsivity as measured by the NIH Flanker
timeFrame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
measure: Change in weight
timeFrame: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
Secondary outcomes:
measure: Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS)
timeFrame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
measure: Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P)
timeFrame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
measure: Change in reported binge eating as measured by the Binge Eating Scale (BES)
timeFrame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Shalamar D Sibley, MD
role: PRINCIPAL_INVESTIGATOR
References: