Disorders of Consciousness
Conditions
Brief summary
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
Interventions
DEVICEsham TI
The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
DEVICEreal TI
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.
Sponsors
Zhejiang Provincial People's Hospital
Zhejiang University
Hangzhou Mingzhou Brain Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRS-R (Coma Recovery Scale-revised) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG spectral power | Baseline; Within 1 week post-stimulation | 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. |
| fNIRS-derived hemoglobin concentration changes | fNIRS data were acquired over a 40-min session on each of the 5 treatment days. | Changes in oxygenated hemoglobin (ΔHbO), deoxygenated hemoglobin (ΔHbR), and total hemoglobin (ΔHbT) concentrations were measured using functional near-infrared spectroscopy (fNIRS). |
| GOS-E（Glasgow Outcome Scale - Extended） | 6 months | The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis. |
| Changes in CRS-R subscale scores | Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month 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. |
| Total CRS-R score changes at follow-up | Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month 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. |
| EEG functional connectivity | Baseline; Within 1 week post-stimulation | 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). |
| Auditory steady-state response (ASSR) | Baseline; Within 1 week post-stimulation | 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. |
| fNIRS-derived functional connectivity | fNIRS data were acquired over a 40-min session on each of the 5 treatment days. | Functional connectivity was estimated by calculating Pearson correlation coefficients between fNIRS time series. |
Countries
China
Outcome results
None listed