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tDCS + Cognitive Training for Obesity

N/A
Recruiting
Led By Shalamar D Sibley, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese (BMI>30)
Adults, ages 18 years or older (up to age 80)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months)
Awards & highlights

Study Summary

This trial is investigating whether electrical stimulation can help people with obesity reduce impulsive behavior and lose weight.

Who is the study for?
This trial is for veterans with obesity (BMI>30) who are enrolled in the MOVE! program at Minneapolis VA, aged 18-80, and can understand English. Women of childbearing age must agree to use birth control. Exclusions include substance abuse, severe medical/psychological conditions, history of seizures or head injury, metal implants in the head, pregnancy, certain metabolic disorders or uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests if transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, alongside cognitive training can reduce impulsivity and help manage weight in obese individuals. Participants will receive either active tDCS or a sham (placebo) treatment.See study design
What are the potential side effects?
Possible side effects from tDCS may include mild itching or tingling on the scalp during application, fatigue after sessions, headache or nausea. These are typically short-lived and considered minor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is over 30, indicating obesity.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in task impulsivity as measured by the NIH Flanker
Change in weight
Secondary outcome measures
Change in reported binge eating as measured by the Binge Eating Scale (BES)
Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS)
Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS with Cognitive TrainingExperimental Treatment1 Intervention
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.
Group II: Sham tDCS with Cognitive TrainingPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Transcranial Direct Current Stimulation (tDCS)
2020
N/A
~160

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,911 Total Patients Enrolled
40 Trials studying Obesity
9,963 Patients Enrolled for Obesity
Shalamar D Sibley, MDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Active Transcranial Direct Current Stimulation (tDCS) Clinical Trial Eligibility Overview. Trial Name: NCT05225233 — N/A
Obesity Research Study Groups: Active tDCS with Cognitive Training, Sham tDCS with Cognitive Training
Obesity Clinical Trial 2023: Active Transcranial Direct Current Stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT05225233 — N/A
Active Transcranial Direct Current Stimulation (tDCS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225233 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study open to those aged 65 and above?

"This clinical trial is accepting patients aged 18 and older, so long as they are younger than 80 years old."

Answered by AI

What is the total cohort size of this research project?

"Affirmative. Clinicaltrials.gov hosts information confirming that this medical research is currently seeking participants; it was first posted on August 1st 2022 and last updated 25th of the same month. A total of 124 people need to be recruited from a singular study location."

Answered by AI

Does this research offer enrolment opportunities for participants?

"Clinicaltrials.gov reveals that this research study is actively seeking volunteers; the initial trial post date was August 1, 2022 and it has been revised for the last time on August 25th of the same year."

Answered by AI

Who is eligible to participate in this medical experiment?

"This research initiative is looking to recruit 124 individuals afflicted with obesity, ranging from 18 to 80 years of age. The key requirements are being a Veteran enrolled in the MOVE! Weight Management Program at the Minneapolis VA Health Care System, having a BMI greater than 30, understanding English and self-consenting to study procedures, as well as using reliable birth control if female and of childbearing potential."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Alaska
How old are they?
18 - 65
What site did they apply to?
Minneapolis VA Health Care System, Minneapolis, MN
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I tried lots of diets and had worked for me. For most of my childhood and adult life I’ve struggled with being overweight, and I’ve been stuck in a cycle of binge eating, and specifically binge eating before bed.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Minneapolis VA Health Care System, Minneapolis, MN: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~73 spots leftby Mar 2026