ObesityNCT05225233

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

A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Obesity
What is being tested?: Active Transcranial Direct Current Stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteUnited States
Study dates: 23 Nov 2022to 31 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309

Other trials in United States

About this study

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

Read the detailed description

Two-hundred forty individuals will be screened with the goal of consenting and enrolling up to 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).

Conditions: Obesity
Being tested: Sham Transcranial Direct Current Stimulation (tDCS), Active Transcranial Direct Current Stimulation (tDCS)
Keywords: transcranial direct current stimulation, neuromodulation
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05225233
Study group	Role	What they receive
Active tDCS with Cognitive Training	Experimental	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. Receives: Device: Active Transcranial Direct Current Stimulation (tDCS)
Sham tDCS with Cognitive Training	Sham comparator	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. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 kilograms (kg) between active and sham tDCS (active from baseline to follow up sessions.
Measured: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202231 Dec 2026

First posted4 Feb 2022
Study start23 Nov 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05225233
Sponsor's protocol ID: NURA-009-21S
Other IDs: 5I01CX002121-04
Status last verified: Oct 2026
First submitted: 19 Jan 2022
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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