The Efficacy and Safety of Temporally Interfering in Patients With Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- CRS-R (Coma Recovery Scale-revised)
研究概览
简要总结
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with the international diagnostic criteria for MCS formulated by Giacino in 2002 or the diagnostic criteria for UWS proposed by Laureys in 2010; Patients with disease duration ≥28 days and unconscious improvement tendency in the past one month; No use of any sedative drugs or antiepileptic drugs (sodium or calcium channel blockers) in the past 1 month; stable vital signs; No obvious brain edema, hydrocephalus, and severe brain atrophy; Age from 18 to 80 years old; Informed consent was obtained from the patients' family members.
排除标准
- •Previous history of neurological or psychiatric disorders; Prior traumatic brain injury unrelated to the index injury; History of cancer; Taking sedative drugs or antiepileptic drugs in the past 1 month; Unstable vital signs; Skull defect; The patients' family members did not sign the informed consent.
研究组 & 干预措施
Sham comparator
Participants receive sham TI stimulation one session per day for 5 consecutive days
干预措施: sham TI (Device)
real TI stimulation
Participants receive real TI stimulation one session per day for 5 consecutive days
干预措施: real TI (Device)
结局指标
主要结局
CRS-R (Coma Recovery Scale-revised)
时间窗: Baseline; Within 1 week post-stimulation
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
次要结局
- EEG spectral power(Baseline; Within 1 week post-stimulation)
- fNIRS-derived hemoglobin concentration changes(fNIRS data were acquired over a 40-min session on each of the 5 treatment days.)
- GOS-E（Glasgow Outcome Scale - Extended）(6 months)
- Changes in CRS-R subscale scores(Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.)
- Total CRS-R score changes at follow-up(Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.)
- EEG functional connectivity(Baseline; Within 1 week post-stimulation)
- Auditory steady-state response (ASSR)(Baseline; Within 1 week post-stimulation)
- fNIRS-derived functional connectivity(fNIRS data were acquired over a 40-min session on each of the 5 treatment days.)
研究者
Li Zhang, MD
Doctor
Zhejiang Provincial People's Hospital