NCT02362542

Brief Summary

The purpose of this study is to investigate the 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
15

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

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)

    Immediately after intervention

Secondary Outcomes (1)

  • Behavior outcomes on the visual analog scale

    Immediately after intervention

Study Arms (2)

Sham tDCS

EXPERIMENTAL

Subjects will receive tDCS two times, one is active stimulation and the other is sham stimulation. Both stimulations will be separated at least one week and the order of sham and active tDCS will be counterbalanced across subjects.

Device: tDCS

Real tDCS

EXPERIMENTAL

Subjects will receive tDCS two times, one is active stimulation and the other is sham stimulation. Both stimulations will be separated at least one week and the order of sham and active tDCS will be counterbalanced across subjects.

Device: tDCS

Interventions

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 tDCSSham tDCS

Eligibility Criteria

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

You may qualify if:

  • BMI \> 28 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

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
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