The Efficacy and Safety of Temporally Interfering in Patients With Disorders of Consciousness
| Registry | NCT06822192 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 28 (Actual) |
| Sponsor | Zhejiang Provincial People's Hospital (Other); collaborators: First Affiliated Hospital of Zhejiang University, Hangzhou Mingzhou Brain Rehabilitation Hospital |
| Conditions | Disorders of Consciousness |
| Interventions | sham TI, real TI (Device) |
| Dates | start 2025-01-20, primary completion 2025-10-31, completion 2026-04-30, first posted 2025-02-12, last updated 2026-07-22 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Disorders of Consciousness All trials of sham TI All trials of real TI
-Summary
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Sham comparator | Sham comparator | Device: sham TI | Participants receive sham TI stimulation one session per day for 5 consecutive days |
| real TI stimulation | Active comparator | Device: real TI | Participants receive real TI stimulation one session per day for 5 consecutive days |
- sham TI (Device): The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
- real TI (Device): 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.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Hangzhou Mingzhou Brain Rehabilitation Hospital | Hangzhou, Zhejiang | China | |
+Publications
- Results publication: Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023. PMID 37780965
- Results publication: Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12. PMID 39133053