The Temporally Interfering in Patients with Disorders of Consciousness

Not Applicable

Not yet recruiting

• Conditions: Disorders of Consciousness

• Registration Number: NCT06822192
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief Summary

This project will help the patient recover consciousness by giving TI (temporally interfering) treatment

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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 70 years old; Informed consent was obtained from the patients' family members.

Exclusion Criteria

Previous history of neurological or psychiatric disorders; Previous history of traumatic brain 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CRS-R (Coma Recovery Scale-revised)	One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus	The CRS-R scale, with scores ranging from 0 to 23, can help to distinguish unresponsive arousal syndrome from micro-conscious states.
Adverse reactions	One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus	Any adverse events related to the study

Secondary Outcome Measures

Name	Time	Method
EEG	One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus	phase-locked values, α, β and other EEG power
GOS-E（Glasgow Outcome Scale - Extended）	2 weeks, 1 month, and 3 months after the end of stimulation	The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.
fNIRS（functional near-infrared spectroscopy）	One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus	functional connectivity