Transcranial Direct Current Stimulation (TDCS) for Electrotherapy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Electrotherapy+3 MoreTranscranial Direct Current Stimulation (TDCS) - Device
Eligibility
18 - 60
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Electrotherapy
  • Eating Disorder
  • Weight Loss
  • Obesity

Treatment Effectiveness

Study Objectives

5 Primary · 17 Secondary · Reporting Duration: Baseline, 1 year

Baseline, 1 year
weight loss
Baseline, week 9
Correlation between food intake and responses to behavioral tests and neuropsychological performance tests
Effect of tDCS on food intake
Effect of tDCS on macronutrient preferences
Effect of tDCS on responses to behavioral tests and neuropsychological performance tests
food intake
macronutrient preferences
responses to Gormally Binge Eating Questionnaire
responses to MacArthur Scale of Subjective Social Status
responses to Perceived Stress Scale
responses to Three Factor Eating Questionnaire
Week 1
Correlation between food intake and appetitive hormone levels
Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood
responses to Go/No Go Task
responses to Iowa Gambling Task
Year 1
Correlation between weight change and appetitive hormone levels
Correlation between weight change and responses to behavioral tests and neuropsychological performance tests
Effect of tDCS on weight loss
Weeks 1 and 9
Effect of tDCS on appetitive hormone levels
Effect of tDCS on brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues
GLP-1
Ghrelin
Brain

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

7 Treatment Groups

2-Active
1 of 7
3-Active
1 of 7
Active
1 of 7
2-Sham
1 of 7
1-Sham
1 of 7
3-Sham
1 of 7
Sham
1 of 7

Active Control

Experimental Treatment

Non-Treatment Group

148 Total Participants · 7 Treatment Groups

Primary Treatment: Transcranial Direct Current Stimulation (TDCS) · Has Placebo Group · Phase 2

Active
Device
Experimental Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device
2-Active
Device
ActiveComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device
2-Sham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: Other
3-Active
Device
ActiveComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device
1-Sham
Device
ShamComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (TDCS) · Intervention Types: Device
3-Sham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: Other
Sham
Other
ShamComparator Group · 1 Intervention: Sham/no-stimulation · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 year

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,148 Previous Clinical Trials
4,074,631 Total Patients Enrolled
Marci E Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
5,000 Total Patients Enrolled
Marci Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
5,100 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 4 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
NIDDK, Phoenix100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References