- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362633
Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Study Overview
Detailed Description
Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a variety of clinical conditions. In addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity.
The investigators aim to assess whether long-term modulation of the dorsolateral prefrontal cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually presented food cues and taste cues in obese subjects.
Subjects will be randomly divided into sham and real tDCS arms. Subjects will receive sham or real tDCS ten times. Subjects will be investigated before and after sham or real tDCS interventions. Subjects will perform functional MRI experiments with visual and taste food cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Chungcheongbuk-Do
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Cheongju, Chungcheongbuk-Do, Korea, Republic of, 361-711
- Chungbuk National University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI > 26 kg/m2
Exclusion Criteria:
- History of brain trauma, epilepsy, or other neurological problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real tDCS
Subjects will receive real tDCS treatment for ten times for two weeks (five times per week).
|
For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times.
The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function.
The electrodes used for tDCS are saline-soaked sponges (25 cm2).
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Sham Comparator: Sham tDCS
Subjects will receive sham tDCS treatment for ten times for two weeks (five times per week).
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Sham tDCS will be delivered for 20 minutes.
The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function.
The electrodes used for tDCS are saline-soaked sponges (25 cm2).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regional brain activity measured by blood-oxygen-level dependent (BOLD) signal of functional MRI
Time Frame: Day 14 (After ten interventions)
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3T MR scanner with Echo Planar Imaging(EPI) capability(Magnetom, Siemens Medical System)
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Day 14 (After ten interventions)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior outcomes on the visual analog scale
Time Frame: Day 14 (After ten interventions)
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Hunger related visual analogue scale (VAS) - 8 items (Flint et al., 2000) Mood related visual analogue scale (VAS) - 16 items (Fregni et al., 2008)
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Day 14 (After ten interventions)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-07-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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