An interventional study of sham TI and real TI in Disorders of Consciousness, sponsored by Zhejiang Provincial People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 147 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Participants receive sham TI stimulation one session per day for 5 consecutive days
Device: sham TI
Participants receive real TI stimulation one session per day for 5 consecutive days
Device: real TI
The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
Stimulation was delivered as two sinusoidal alternating currents with carrier frequencies of 2000 Hz and 2010 Hz, generating a 10 Hz amplitude-modulated envelope. Current intensity was set at 3 mA per channel. Each session included 30-second ramp-up and ramp-down periods at the beginning and end of stimulation.
CRS-R (Coma Recovery Scale-revised)
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.
Time frame: Baseline; Within 1 week post-stimulation
EEG spectral power
EEG spectral power was quantified across five canonical frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz). Relative power spectral density (PSD) was calculated for each frequency band.
Time frame: Baseline; Within 1 week post-stimulation
fNIRS-derived hemoglobin concentration changes
Changes in oxygenated hemoglobin (ΔHbO), deoxygenated hemoglobin (ΔHbR), and total hemoglobin (ΔHbT) concentrations were measured using functional near-infrared spectroscopy (fNIRS).
Time frame: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
GOS-E（Glasgow Outcome Scale - Extended）
The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.
Time frame: 6 months
Changes in CRS-R subscale scores
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.
Time frame: 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
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.
Time frame: Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
EEG functional connectivity
EEG functional connectivity was quantified using phase-locking value (PLV) across five frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
Time frame: Baseline; Within 1 week post-stimulation
Auditory steady-state response (ASSR)
ASSR was recorded during EEG while participants listened to modulated tones. ASSR strength was quantified using an amplitude-based signal-to-noise ratio (SNR), calculated as the amplitude at the target frequency divided by the mean amplitude of the surrounding spectral background.
Time frame: Baseline; Within 1 week post-stimulation
fNIRS-derived functional connectivity
Functional connectivity was estimated by calculating Pearson correlation coefficients between fNIRS time series.
Time frame: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial People's Hospital