- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07591194
The Effects of Immersive Virtual Reality-Based Exergaming Combined With Transcranial Direct Current Stimulation on Executive Functions in Healthy Older Adults
The goal of this clinical trial is to investigate the acute effects of immersive virtual reality (VR)-based exergaming combined with transcranial direct current stimulation (tDCS) on executive functions in healthy older adults. The main questions it aims to answer are:
- Does VR-based exergaming combined with tDCS improve executive function performance in healthy older adults compared with a control condition?
- Do single interventions (tDCS alone or VR-based exergaming alone) improve executive function performance compared with the control condition?
- Does the combined intervention produce greater improvements in executive function performance than either intervention alone? Researchers will compare four intervention conditions to evaluate differences in executive function performance following each session.
Participants will:
- Complete four intervention sessions in a randomized crossover sequence, with a washout period of at least 7 days between sessions
- Receive the following intervention conditions:
- sham-tDCS + VR-video
- tDCS + VR-video
- sham-tDCS + VR-exergaming
- tDCS + VR-exergaming
- Complete executive function assessments immediately after each session, including:
- the Flanker task for inhibitory control
- the more-odd shifting task for cognitive flexibility
- the Corsi block-tapping task for working memory
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mengdie Hu
- 전화번호: 86+13011852188
- 이메일: mengdie.hu0818@hotmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
(1) Age between 60 to 70 years old; (2) Right-handed (Edinburgh Handedness Inventory (Chinese version) > 40); (3) Normal overall cognitive function (Montreal Cognitive Assessment (Beijing version) ≥ 26).
Exclusion Criteria:
(1) Musculoskeletal injury; (2) neurological/neurodegenerative disorders (e.g., Alzheimer's disease); (3) history of brain infections or cerebrovascular diseases; (4) psychiatric disorders (e.g., major depressive disorder, schizophrenia); (5) unstable or chronic medical conditions (e.g., cardiac disease, seizures (personal/family history)); (6) hearing and visual impairments (e.g., color blindness and conditions severely affecting the ability to see the screen or distinguish colors); (7) metal implants (e.g., pacemakers); (8) brain stimulation or exercise training intervention within the past 6 months; (9) failure to meet safety criteria for brain stimulation (e.g., pregnancy)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
가짜 비교기: Sham tDCS + VR-video
Participants receive sham transcranial direct current stimulation and then watch a virtual reality video.
|
The anodal electrode is positioned over the left DLPFC (F3), and the cathodal electrode is placed over the right supraorbital area.
Sham stimulation is applied in the same locations for 20 min with only 15s ramp-up and 15s ramp-down stimulation to mimic the sensory experience of real stimulation.
For the VR-video condition, participants view a mild plant documentary called Journey of Chinese Plants through the same VR headset.
VR-video intervention consisted of four cycles of 3.5 min, each separated by a 2-min rest interval, for a total duration of 20 min
|
|
실험적: tDCS + VR-video
Participants receive active transcranial direct current stimulation and then watch a virtual reality video.
|
For the VR-video condition, participants view a mild plant documentary called Journey of Chinese Plants through the same VR headset.
VR-video intervention consisted of four cycles of 3.5 min, each separated by a 2-min rest interval, for a total duration of 20 min
The anodal electrode is positioned over the left DLPFC (F3), and the cathodal electrode is placed over the right supraorbital area.
The transcranial direct current stimulation is applied for 20 min at an intensity of 2 mA, with 15 s ramp-up and 15 s ramp-down.
|
|
실험적: Sham tDCS + VR-exergaming
Participants receive sham transcranial direct current stimulation combined with immersive virtual reality-based exergaming.
|
The anodal electrode is positioned over the left DLPFC (F3), and the cathodal electrode is placed over the right supraorbital area.
Sham stimulation is applied in the same locations for 20 min with only 15s ramp-up and 15s ramp-down stimulation to mimic the sensory experience of real stimulation.
For the VR-exergaming condition, participants engage in an interactive rhythm-based fitness game called PowerBeatsVR.
It immerses participants in a virtual exercise environment accompanied by dynamic musical beats, with punching and tracking movements.
The VR-exergaming consisted of four cycles of 3.5 min, each separated by a 2-min rest interval, for a total duration of 20 min
|
|
실험적: tDCS + VR-exergaming
Participants receive active transcranial direct current stimulation combined with immersive virtual reality-based exergaming.
|
The anodal electrode is positioned over the left DLPFC (F3), and the cathodal electrode is placed over the right supraorbital area.
The transcranial direct current stimulation is applied for 20 min at an intensity of 2 mA, with 15 s ramp-up and 15 s ramp-down.
For the VR-exergaming condition, participants engage in an interactive rhythm-based fitness game called PowerBeatsVR.
It immerses participants in a virtual exercise environment accompanied by dynamic musical beats, with punching and tracking movements.
The VR-exergaming consisted of four cycles of 3.5 min, each separated by a 2-min rest interval, for a total duration of 20 min
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Reaction time and accuracy of inhibitory control are assessed by the Flanker task.
기간: Immediately after the intervention.
|
Immediately after the intervention.
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Reaction time and accuracy of cognitive flexibility are assessed by more odds shifting task.
기간: Immediately after the intervention.
|
Immediately after the intervention.
|
|
Scores of working memory are assessed by the Corsi Block-Tapping Task
기간: Immediately after the intervention.
|
Immediately after the intervention.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024458H
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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