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작성일 : 10-05-12 10:22
뇌파, 맥파 1500개 분석지표의 임상시험 및 표준화 성공
 글쓴이 : 펀펀브레인
조회 : 11,316  

□ 교과부 21세기 뇌프론티어사업단(단장 김경진)은 표준화에 성공한 1509개의 뇌파, 맥파 분석지표를 기반으로 뇌-기계 접속기술을 개발함으로써 제품화를 추진한다고 발표하였다.

 

○ 뇌-기계 접속기술(Brain-machine Interface, BMI) 21세기 최첨단 미래기술 중 하나로써 인체에 직접 연결되는 침습적 기술과 인체 손상없는 비침습적 기술로 연구되고 있으며 이번 뇌프론티어사업단에서 제품화하는 기술은 비침습적 뇌-기계접속기술중 뇌파 (electroencephalogram, EEG)와 광용적맥파(photo-plethysmogram, PTG)의 표준화 임상시험을 거쳐 확보된 1500여개의 방대한 분석지표를 기반으로 함이 주요 특징이다.

 

□ 이번 연구성과는 뇌프론티어사업단 뇌-기계 접속기술 연구개발과제의 참여기업인 ()락싸에서 개발한 것으로연구팀(락싸기술연구소, 최정미소장)은 연구개발을 위하여 서울아산병원 임상시험심사위원회(IRB)의 승인을 받은 시험계획서에 따라 동 병원 임상연구센터에 의뢰하여 식품의약품안전청 및 ICH(The International Conference on Harmonisation)가 정한 임상시험관리기준(GCP)에 준하여 임상시험을 수행하였다대량 확보된 데이터들을 신호분석/통계처리하여 표준화된 임상DB를 구축하였고, 관련 특허 4건을 등록 완료하였다.

 

○ 임상 데이타는 건강한 자원자를 대상으로 확보되었으며, 뇌파에서는 눈감은 안정기능, 눈뜬 각성기능, 주의기능, 고차인지기능 4가지 검사를 통하여 총 1467 (323/283/510/351)의 뇌기능관련 분석지표들이 추출되었다. 맥파에서는 심박변이도와 가속도맥파 분석을 통해 총 42개의 자율신경관련 지표들이 추출되었으며, 이후 통계처리과정에 의해 정상여부 판별이 가능한 성별, 연령대별 표준범위가 확보되었다. 뿐만 아니라, 연령대 증가에 따라 선형적으로 비례하는 지표들도 다수 발견되어 뇌기능 및 자율신경기능 노화의 정량적 평가까지 가능해진 점도 응용 파급효과가 큰 획기적인 성과이다.

 

○ 특히, 이번 연구 성과는 총 1500여개의 뇌기능 검사, 뇌기능 항진 및 자율신경기능 검사 지표들에 대해 성별, 연령대별 통계기반 객관적 임상해석 기준을 세계 최초로 국제적 공신력 있게 확립한 것으로써 뇌파, 자율신경기반 헬스케어 분야를 기술적으로 한 단계 도약시킬 수 있는 발판을 마련하였을 뿐 아니라, 임상해석의 자동화가 가능해지므로 IT기술과의 융합을 통해 대중적 응용까지 폭넓게 모색할 수 있는 길을 열었다.

 

○ 연구팀은 연구성과를 자체실용화로 추진할 예정이며, 향후 500억원이상의 시장 창출 효과가 있을 것으로 내다보고 있다.

 

                     

  

뇌파,맥파 분석지표들의 통계적 표준화를 위한 임상시험 결과보고서

(총2권/3344 Page)

 

 

 

뇌파,맥파 분석지표의 임상통계적 표준점수 표시 및 노화에 따른 선형비례 특징 예 

 

 

□ 연구팀은 응용 목적에 맞는 임상지표들을 선별한 후 API(Application Program Interface) 형식으로 모듈화 한, ‘뉴로니클 API라는 브랜드의 생체신호 응용상품개발용 소프트웨어를 수요업체에 공급하고 있다. 따라서 수요업체들은 원천기술을 쉽게 활용하여 상품화할 수 있게 된다.

 

○ 뉴로니클 API는 실시간으로 측정되는 생체신호로부터 다단계 수치계산과정을 통하여 분석지표를 산출하여 응용프로그램에 제공해 준다. 뉴로니클 API에서의 분석지표들은 종래의 방식처럼 단순히 값만 제공하는 것이 아니라, 표준화된 임상데이터를 기반으로 하여 해당 값이 표준 대비 정상인지 비정상인지 판단 가능한 정보를 함께 제공함이 주요한 특징이다.

 

○ 소프트웨어 개발자는 응용프로그램에서 생체신호를 활용하기 위하여, 기초 연구부터 시행되어야 하는 방대한 작업을 수행하지 않아도 되며, 부품을 도입하듯이 뉴로니클 API를 도입하면 신뢰도가 높은 최종 생체신호 분석지표를 자신의 응용프로그램에서 구현할 수 있게 된다.

 

○ 뉴로니클 API는 활용 목적에 따라 뇌파게임, 뇌노화검사, 학습능력검사, 집중력모니터링, 스트레스검사, 이완훈련 등 그 활용범위가 다양하다. 따라서 IT기기와의 융합을 통해 U-헬쓰케어, 이러닝(E-Learning) 교육, 문화컨텐츠, 게임산업과 같은 대중적인 분야의 상품들에도 쉽게 도입될 수 있다.

 

□ 본 기술로 가능한 실용화 제품들 중 헤어밴드와 반지형 센서를 통한 두뇌검사/훈련과 스트레스 검사는 조만간 일반인도 쉽게 접하게 될 전망이다. 헤어밴드를 이마에 착용하면 전두엽 부위 뇌파가 ‘뉴로니클 API'에 의하여 자동 해석되어 집중력, 인지강도, 안정도, 좌우뇌균형 등의 두뇌검사가 가능하고, 집중력 정도에 따라 조종되는 뇌파게임도 가능해진다.

 

○ 또한, 손가락에 반지형센서를 착용하면 맥파가 측정되고, 이 신호 역시 ‘뉴로니클 API'에 의하여 자동 해석되어 자율신경반응에 의한 스트레스 수준을 알 수 있게 된다.


(관련기사보러가기)


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