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

Primary Purpose

Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sham Transcranial Direct Current Stimulation (tDCS)

Active Transcranial Direct Current Stimulation (tDCS)

About this trial

This is an interventional treatment trial for Obesity focused on measuring transcranial direct current stimulation, neuromodulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Minneapolis VA Health Care System, Minneapolis, MNRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS with Cognitive Training

Sham tDCS with Cognitive Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 in weight

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

Secondary Outcome Measures

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 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 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.

Full Information

NCT ID

NCT05225233

First Posted

January 19, 2022

Last Updated

August 2, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05225233

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 23, 2022 (Actual)

Primary Completion Date

March 14, 2026 (Anticipated)

Study Completion Date

April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

transcranial direct current stimulation, neuromodulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS with Cognitive Training

Arm Type

Experimental

Arm Description

Arm Title

Sham tDCS with Cognitive Training

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Description

Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session)

Intervention Type

Device

Intervention Name(s)

Active Transcranial Direct Current Stimulation (tDCS)

Intervention Description

Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Primary Outcome Measure Information:

Title

Change in task impulsivity as measured by the NIH Flanker

Description

Differences in the magnitude of change in NIH Flanker Reaction Time (RT) (ms) between active and sham groups from baseline to follow up sessions.

Time Frame

Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

Title

Change in weight

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS)

Description

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.

Time Frame

Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

Title

Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P)

Description

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.

Time Frame

Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

Title

Change in reported binge eating as measured by the Binge Eating Scale (BES)

Description

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.

Time Frame

Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shalamar D Sibley, MD

Phone

(612) 725-2000

Ext

4424

Shalamar.Sibley@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa E Keacher, BS

Phone

(612) 467-5203

lisa.keacher@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shalamar D Sibley, MD

Organizational Affiliation

Minneapolis VA Health Care System, Minneapolis, MN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minneapolis VA Health Care System, Minneapolis, MN

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417-2309

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shalamar D Sibley, MD

Phone

612-725-2000

Ext

4424

Shalamar.Sibley@va.gov

First Name & Middle Initial & Last Name & Degree

Shalamar D Sibley, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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