Status Approved
First Submitted Date
2020/10/07
Registered Date
2020/10/15
Last Updated Date
2020/11/03
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005492 |
|---|---|
| Unique Protocol ID | VC19DISS0263 |
| Public/Brief Title | The effects of transcranial magnetic stimulation on eating behaviors and body weight in obese patient with depression |
| Scientific Title | The effects of transcranial magnetic stimulation on eating behaviors and body weight in obese patient with depression: A Randomized Controlled Study |
| Acronym | ETBUS_ID |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | VC19DISS0263 |
| Approval Date | 2020-01-19 |
| Institutional Review Board Name | St. Vincent's Hospital IRB |
| Institutional Review Board Address | 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do |
| Institutional Review Board Telephone | 031-249-8289 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Se-hong Kim |
| Title | MD, PhD |
| Telephone | +82-31-820-8061 |
| Affiliation | The Catholic University of Korea |
| Address | 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do |
| Contact Person for Public Queries | |
| Name | Se-hong Kim |
| Title | MD, PhD |
| Telephone | +82-31-820-8061 |
| Affiliation | The Catholic University of Korea |
| Address | 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do |
| Contact Person for Updating Information | |
| Name | Se-hong Kim |
| Title | MD, PhD |
| Telephone | +82-31-820-8061 |
| Affiliation | The Catholic University of Korea |
| Address | 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-01-19 Actual | |
| Target Number of Participant | 40 | |
| Primary Completion Date | 2020-12-25 , Anticipated | |
| Study Completion Date | 2020-12-25 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | The Catholic University of Korea, St. Vincent's Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-01-19 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Ministry of Science and ICT |
| Organization Type | Government |
| Project ID | CPS-19-04-KRIBB |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | The Catholic University of Korea, St. Vincent's Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Depressed patients often have eating disorders together, and the degree of depression and obesity influence each other. Obesity is a result of cravaing and accompanies neurological changes related to food addiction, so transcranial magnetic stimulation (TMS) control of the brain region involved in the addiction mechanism is an effective treatment alternative. The purpose of this study is to evaluate the effectiveness and safety of weight control after transcranial magnetic stimulation in obese depressed patients. The duration of this clinical trial is 4 weeks (excluding screening period), and transcranial magnetic stimulation is performed twice a week for 4 weeks according to the protocol in obese depressed patients. The changes in body weight before and after the transcranial magnetic stimulation intervention are evaluated primarily, and the changes in dietary intake and eating behavior and changes in the neural network are evaluated using a questionnaire survey and structural and functional magnetic resonance imaging. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Treatment |
| Phase | Phase2 |
| Intervention Model | Parallel |
| Blinding/Masking | Single |
| Blinded Subject | Subject |
| Allocation | RCT |
| Intervention Type | Medical Device |
| Intervention Description | Device: rTMS - Repetitive Transcranial Magnetic Stimulation(rTMS) has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex. - Proposed schedule of treatment: frequency of 50Hz and intensity of 80~100% of the individual's motor threshold (600 pulses per session): 19 trains of 2 sec. with 8-sec. inter-train intervals will be administered over 3 min.; 2 days/week, 8 sessions. - Sham Transcranial Magnetic Stimulation (TMS): 20 obese individuals will be randomized to receive sham TMS treatment (2 days/week, total 8 sessions for 4 weeks). For sham stimulation, the TMS coil was placed over the interhemispheric fissure on the vertex at 90° to the scalp, and stimulation with low intensity (10% resting motor threshold) was given to elicit similar skin sensations as real stimulation. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label Experimental group: repetitive Transcranial Magnetic Stimulation(rTMS) |
|
Target Number of Participant 20 |
|
|
Arm Type Experimental |
|
|
Arm Description 20 obese individuals meeting criteria for the study will be randomized to active rTMS treatment. - Proposed schedule of treatment: frequency of 50Hz and intensity of 80~100% of the individual's motor threshold (600 pulses per session): 19 trains of 2 sec. with 8-sec. inter-train intervals will be administered over 3 min.; 2 days/week, 8 sessions. |
|
| Arm 2 |
Arm Label Sham Comparator: Sham Transcranial Magnetic Stimulation(TMS) |
|
Target Number of Participant 20 |
|
|
Arm Type Sham comparator |
|
|
Arm Description 20 obese individuals will be randomized to receive sham TMS treatment (2 days/week, total 8 sessions for 4 weeks). For sham stimulation, the TMS coil was placed over the interhemispheric fissure on the vertex at 90° to the scalp, and stimulation with low intensity (10% resting motor threshold) was given to elicit similar skin sensations as real stimulation. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F32.9)Depressive episode, unspecified Depression, Obesity, Overweight |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~70Year |
|
|
Description - 19 to 70 years old - BMI ≥ 25kg/m2 - Diagnosis and Statistics Handbook for Mental Disorders-Patients diagnosed as depressive disorder according to the 5th edition (DSM-V) diagnostic criteria and showing moderate symptoms (BDI 14~28 points) - Patients taking 2 or less antidepressants at a stable dose for the last 4 weeks |
|
| Exclusion Criteria |
• Past history of head or eye injury or epilepsy • Body metallic implants, pacemaker, claustrophobia and any other contraindication to fMRI or rTMS; • Current use of psychotropic drugs (except for antidepressants on a stable dose for at least one month) • Current use of any anti-obesity drug (three months washout period for any other medication) • Pregnancy or breast feeding • Past history of Diabetes Mellitus, thyroid disease, renal disease and malignancy • Major psychiatric disorder requiring immediate treatment • Substance dependence • Individuals currently receiving any psychological therapy for their eating disorder • Substance dependence • severe infection, metabollic acidosis, acromegaly adn Cushing syndrome |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Change in Body Weight |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Korean eating attitude test (KEAT-26) scores |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 2 | ||
| Outcome | visceral fat assessed by CT |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 3 | ||
| Outcome | structural and functionl change assessed by brain MRI |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 4 | ||
| Outcome | CERAD-K score |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 5 | ||
| Outcome | Beck Depression Inventory score |
|
| Timepoint | baseline and 4 weeks |
|
| Secondary Outcome(s) 6 | ||
| Outcome | dopamine, serotonin, cortisol |
|
| Timepoint | baseline and 4 weeks |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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