NCT02362633

Brief Summary

The purpose of this study is to investigate the long-term effect of Transcranial Direct Current Stimulation (tDCS) on appetite control related brain regions.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

February 2, 2015

Last Update Submit

February 3, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Regional brain activity measured by blood-oxygen-level dependent (BOLD) signal of functional MRI

    3T MR scanner with Echo Planar Imaging(EPI) capability(Magnetom, Siemens Medical System)

    Day 14 (After ten interventions)

Secondary Outcomes (1)

  • Behavior outcomes on the visual analog scale

    Day 14 (After ten interventions)

Study Arms (2)

Real tDCS

EXPERIMENTAL

Subjects will receive real tDCS treatment for ten times for two weeks (five times per week).

Device: real tDCS

Sham tDCS

SHAM COMPARATOR

Subjects will receive sham tDCS treatment for ten times for two weeks (five times per week).

Device: sham tDCS

Interventions

real tDCSDEVICE

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).

Real tDCS
sham tDCSDEVICE

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).

Sham tDCS

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 26 kg/m2

You may not qualify if:

  • History of brain trauma, epilepsy, or other neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

KR(1)