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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: Active Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

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).

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shalamar D Sibley, MD; Phone Number: 4424 (612) 725-2000; Email: Shalamar.Sibley@va.gov
• Study Contact Backup: Name: Lisa E Keacher, BS; Phone Number: (612) 467-5203; Email: lisa.keacher@va.gov

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417-2309
      • Recruiting
      • Minneapolis VA Health Care System, Minneapolis, MN
      • Contact: Shalamar D Sibley, MD; Phone Number: 4424 612-725-2000; Email: Shalamar.Sibley@va.gov
      • Principal Investigator: Shalamar D Sibley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS with Cognitive Training; Participants will receive active tDCS stimulation with their cognitive training during a one-hour session each day which includes 20 minutes of stimulation at the beginning of a 46-minute task training session. Ten sessions will be completed over three weeks.	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.
Sham Comparator: Sham tDCS with Cognitive Training; Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 seconds, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Shalamar D Sibley, MD, Minneapolis VA Health Care System, Minneapolis, MN

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): March 14, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; neuromodulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Impulsive Behavior
• Other Study ID Numbers: NURA-009-21S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No