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Brain Stimulation for Obesity

Q: Is this research initiative open to participants below the age of eighty?

This medical experiment seeks participants who are of legal age (18 or older) and below the age of 60.

Q: What is the cap on enrollment for this clinical trial?

Affirmative. According to clinicaltrials.gov, this scientific experiment is currently enrolling participants and was first posted on January 19th 2009. A total of 148 patients need to be recruited from 2 sites for the trial's completion; its most recent update was last November 19th 2022.

Q: Are there currently any opportunities to join this clinical trial?

Affirmative. According to the information housed on clinicaltrials.gov, this medical trial went online in January 2009 and has been actively seeking participants since then; it most recently underwent an update on November 19th 2022. The researchers are currently recruiting 148 individuals from two distinct sites for the study.

Q: What are the key goals of this clinical evaluation?

The primary measurement of this trial over a Baseline, week 9 period is to assess the fMRI activation in the left DLPFC when prompted with food and non-food visual cues. Secondary outcomes include responses to Perceived Stress Scale, Gormally <a href="https://www.withpower.com/clinical-trials/binge-eating">Binge eating</a> Questionnaire and MacArthur Scale of Subjective Social Status - each measured as percent signal change in the same area of brain activity when shown food versus non-food visual prompts alongside performance on relevant questionnaires.

Q: Can I be considered for participation in this clinical research?

To qualify for this experiment, hopefuls must have prior exposure to electric stimulation therapy and be within the age ranges of 18-60. An estimated 148 patients are being accepted into the trial.

Q: Is Transcranial Direct Current Stimulation (TDCS) a risk-free procedure?

As this is a Phase 2 trial, with some evidence of safety but none for efficacy, our team at Power gave Transcranial Direct Current Stimulation (<a href="https://www.withpower.com/clinical-trials/tdcs">TDCS</a>) a score of 2.

Phase 2

Recruiting

Led By Marci Gluck, Ph.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI greater than or equal to 25 kg/m(2)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year

Awards & highlights

Study Summary

This trial will study whether electrical stimulation of the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time.

Who is the study for?

This trial is for non-diabetic, right-handed adults aged 18-60 living in Phoenix, AZ with obesity (BMI ≥ 25 kg/m² and weight <350 lbs). Participants should have had a stable weight for the last three months. Exclusions include postmenopausal women, those with conditions affecting appetite or metabolism, recent medication use that affects metabolism/appetite, substance abuse issues, unstable medical conditions, contraindications for MRI scans or any other condition deemed unsafe by the investigator.Check my eligibility

What is being tested?

The study tests if brain stimulation of the dorsolateral prefrontal cortex influences food intake and assists in weight loss over four weeks. It involves initial inpatient testing followed by outpatient visits where participants receive either real transcranial direct current stimulation (TDCS) or sham treatment while maintaining a reduced-calorie diet.See study design

What are the potential side effects?

Possible side effects from TDCS may include tingling under electrodes during the procedure. There are no significant side effects expected from sham treatment. The long-term impact on brain function due to repeated sessions of TDCS is not fully known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is 25 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain

food intake

Secondary outcome measures

GLP-1

Ghrelin

macronutrient preferences

+7 more

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: 2-ActiveActive Control1 Intervention

Active tDCS stimulation

Group II: 3-ActiveActive Control1 Intervention

Active tDCS stimulation

Group III: 3-ShamPlacebo Group1 Intervention

Sham/no-stimulation

Group IV: 1-ShamPlacebo Group1 Intervention

Active tDCS stimulation

Group V: 2-ShamPlacebo Group1 Intervention

Sham/no-stimulation

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,314,443 Total Patients Enrolled

Marci Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

2 Previous Clinical Trials

5,156 Total Patients Enrolled

Marci E Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1 Previous Clinical Trials

5,056 Total Patients Enrolled

Media Library

Transcranial Direct Current Stimulation (TDCS) Clinical Trial Eligibility Overview. Trial Name: NCT00739362 — Phase 2

Electrotherapy Research Study Groups: 3-Sham, 2-Active, 3-Active, 1-Sham, 2-Sham

Electrotherapy Clinical Trial 2023: Transcranial Direct Current Stimulation (TDCS) Highlights & Side Effects. Trial Name: NCT00739362 — Phase 2

Transcranial Direct Current Stimulation (TDCS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00739362 — Phase 2

Electrotherapy Patient Testimony for trial: Trial Name: NCT00739362 — Phase 2

Frequently Asked Questions

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

Is this research initiative open to participants below the age of eighty?

"This medical experiment seeks participants who are of legal age (18 or older) and below the age of 60."

Answered by AI

What is the cap on enrollment for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this scientific experiment is currently enrolling participants and was first posted on January 19th 2009. A total of 148 patients need to be recruited from 2 sites for the trial's completion; its most recent update was last November 19th 2022."

Answered by AI

Are there currently any opportunities to join this clinical trial?

"Affirmative. According to the information housed on clinicaltrials.gov, this medical trial went online in January 2009 and has been actively seeking participants since then; it most recently underwent an update on November 19th 2022. The researchers are currently recruiting 148 individuals from two distinct sites for the study."

Answered by AI

What are the key goals of this clinical evaluation?

"The primary measurement of this trial over a Baseline, week 9 period is to assess the fMRI activation in the left DLPFC when prompted with food and non-food visual cues. Secondary outcomes include responses to Perceived Stress Scale, Gormally Binge eating Questionnaire and MacArthur Scale of Subjective Social Status - each measured as percent signal change in the same area of brain activity when shown food versus non-food visual prompts alongside performance on relevant questionnaires."

Answered by AI

Can I be considered for participation in this clinical research?

"To qualify for this experiment, hopefuls must have prior exposure to electric stimulation therapy and be within the age ranges of 18-60. An estimated 148 patients are being accepted into the trial."

Answered by AI

Is Transcranial Direct Current Stimulation (TDCS) a risk-free procedure?

"As this is a Phase 2 trial, with some evidence of safety but none for efficacy, our team at Power gave Transcranial Direct Current Stimulation (TDCS) a score of 2."

Answered by AI

Who else is applying?

What state do they live in?

British Columbia

Arizona

How old are they?

18 - 65

What site did they apply to?

Banner Alzheimer's Institute

NIDDK, Phoenix

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I tried working out. Hoping this trial will help me with weightloss. I was on monjaro I was SO amazi h for me . I cannot get my Insurance to cover it now since I do t ja e diabetes so I'm turning to clinical trials.

PatientReceived no prior treatments