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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225233
• Other study ID #: NURA-009-21S
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Shalamar D Sibley, MD
• Phone: (612) 725-2000
• Email: Shalamar.Sibley[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 30, 2026
• Est. primary completion date: March 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impulsive Behavior
• Obesity

Intervention

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)
• Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)