Status Approved
First Submitted Date
2018/11/07
Registered Date
2019/01/16
Last Updated Date
2018/12/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003433 |
---|---|
Unique Protocol ID | DJDSKH-18-BM-12 |
Public/Brief Title | A exploratory study for compliance and validation of Neurofeedback in mild cognitive impairment |
Scientific Title | A exploratory study for compliance and validation of Neurofeedback in mild cognitive impairment |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
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 | DJDSKH-18-BM-12 |
Approval Date | 2018-07-04 |
Institutional Review Board Name | Institutional Reveiw Board Dunsan Korea Medicine Hospital |
Institutional Review Board Address | 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon |
Institutional Review Board Telephone | 042-470-9488 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Horyong Yoo |
Title | Professor |
Telephone | +82-42-470-9131 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon |
Contact Person for Public Queries | |
Name | Jung-Hee Jang |
Title | Researcher |
Telephone | +82-42-470-9490 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon |
Contact Person for Updating Information | |
Name | Jung-Hee Jang |
Title | Researcher |
Telephone | +82-42-470-9490 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-10-01 Actual | |
Target Number of Participant | 5 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Daejeon Korean Medicine Hospital of Daejeon University | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-10-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
7. Study Summary
Lay Summary | Purpose: To evaluate compliance and validation of the neurofeedback training in patients with mild cognitive impairment, and to identify hemodynamic change on cerebral cortical using f-NIRS. Background: The importance of prevention, treatment and management of geriatric diseases, especially dementia, is increasing according to aging. Neurofeedback is a training method that measures brain waves and selectively feeds back to brain to improve your homeostasis. This training can improve emotional, behavioral, learning, and health have. Recently, neurofeedback training for dementia patients and healthy people has been reported to improve brain activation. In this study, we aimed to evaluate the effectiveness of neurofeedback in patients with mild cognitive impairment, a pre-dementia stage. Clinical study plan: This is an exploratory study to evaluate cognitive function improvement and cerebral hemodynamic change in 5 patients with mild cognitive impairment by performing neurofeedback training twice a week and 16 times for 8 weeks. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Medical Device |
Intervention Description | Neurofeedback was performed through a single-channel EEG signal measurement of the dorsolateral prefrontal cortex (dlPFC) (Thought Technology Ltd.'s Neurofeedback). Previous research reported that patients with mild cognitive impairment had reduced alpha-waves (8 to 10.5 Hz) in the prefrontal cortex compared to healthy controls. In this study, the respiration method to regulate the EEG activity of the brain region of interest is divided into concentrating on the nascent, concentrating on the drinking, and concentrating on the subject's autonomous breathing. One session of neurofeedback consists of 5 minutes, which is repeated 9 times. Subjects perform neurofeedback using breathing methods that were instructed by the experimenter. In order to measure the respiration rate volume of the subject, respiratory of subject record by belt. Subjects were asked to measure the mean state of the EEG band before and during the neurofeedback session in a relaxed state (~ 30 seconds, natural respiration in a comfortable posture, open eyes and no visual stimulation) and set the threshold value. In the subsequent neurofeedback session, the threshold value of the next session is set according to the feedback level of the subject. |
Number of Arms | 1 |
Arm 1 |
Arm Label Training group |
Target Number of Participant 5 |
|
Arm Type Experimental |
|
Arm Description Neurofeedback was performed through a single-channel EEG signal measurement of the dorsolateral prefrontal cortex (dlPFC) (Thought Technology Ltd.'s Neurofeedback). Previous research reported that patients with mild cognitive impairment had reduced alpha-waves (8 to 10.5 Hz) in the prefrontal cortex compared to healthy controls. In this study, the respiration method to regulate the EEG activity of the brain region of interest is divided into concentrating on the nascent, concentrating on the drinking, and concentrating on the subject's autonomous breathing. One session of neurofeedback consists of 5 minutes, which is repeated 9 times. Subjects perform neurofeedback using breathing methods that were instructed by the experimenter. In order to measure the respiration rate volume of the subject, respiratory of subject record by belt. Subjects were asked to measure the mean state of the EEG band before and during the neurofeedback session in a relaxed state (~ 30 seconds, natural respiration in a comfortable posture, open eyes and no visual stimulation) and set the threshold value. In the subsequent neurofeedback session, the threshold value of the next session is set according to the feedback level of the subject. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F06.7)Mild cognitive disorder Cognitive Dysfunction |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 40Year~80Year |
|
Description - Individuals 40 to 80 years of age - Those who understand the purpose of the study and consent to participate - at least 6 years of education - Individuals who meet the Peterson diagnostic criteria for MCI with memory problems at least for 3 months - Hachinski ischemic score ≤ 6 - Korean version of the Montreal Cognitive Assessment (MoCA-K) score ≤ 22; |
|
Exclusion Criteria |
- Diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) - History of neurological disorder(s) that can cause cognitive decline (e.g., Parkinson's disease, stroke, cerebral hemorrhage, tumors, normal pressure hydrocephalus) - Received any treatment for MCI during the previous 2 weeks - Involved in other clinical trials within the previous 4 weeks - Individuals likely to exhibit a non-cooperative attitude or judged by the researchers to be unable to proceed with the study - Individuals who cannot undergo fNIRS measurements for any reason |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | MoCA-K (Korean version of Montreal Cognitive Assessment) |
|
Timepoint | baseline, visit8, visit16 |
|
Secondary Outcome(s) 1 | ||
Outcome | BDI (Beck Depression Inventory) |
|
Timepoint | visit1, visit8, visit16 |
|
Secondary Outcome(s) 2 | ||
Outcome | CNS vital sign (computerized neurocognitive assessment vital sign) |
|
Timepoint | visit1, visit16 |
|
Secondary Outcome(s) 3 | ||
Outcome | Hemodynamic change during working memory in prefrontal cortex |
|
Timepoint | visit1, visit16 |
|
Secondary Outcome(s) 4 | ||
Outcome | Accuracy of working memory |
|
Timepoint | visit1, visit16 |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
---|
TOP
BOTTOM
화면 최하단으로 이동