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Completed

NCT Number: NCT06822192

The Temporally Interfering in Patients With Disorders of Consciousness

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

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Key information

Conditions

Disorders of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou Mingzhou Brain Rehabilitation Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. CRS-R (Coma Recovery Scale-revised)

    Time frame: 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

  1. EEG spectral power

    Time frame: 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.

  2. fNIRS-derived hemoglobin concentration changes

    Time frame: 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).

  3. GOS-E（Glasgow Outcome Scale - Extended）

    Time frame: 6 months

    The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.

  4. Changes in CRS-R subscale scores

    Time frame: 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.

  5. Total CRS-R score changes at follow-up

    Time frame: 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.

  6. EEG functional connectivity

    Time frame: 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).

  7. Auditory steady-state response (ASSR)

    Time frame: 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.

  8. fNIRS-derived functional connectivity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Collaborators

  • Hangzhou Mingzhou Brain Rehabilitation Hospital
  • Zhejiang University

Registry information

Official study title

The Efficacy and Safety of Temporally Interfering in Patients With Disorders of Consciousness

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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