NCT06822192

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

July 22, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

January 16, 2025

Last Update Submit

July 20, 2026

Conditions

Disorders of Consciousness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline; Within 1 week post-stimulation

Secondary Outcomes (8)

  • EEG spectral power

    Baseline; Within 1 week post-stimulation

  • fNIRS-derived hemoglobin concentration changes

    fNIRS data were acquired over a 40-min session on each of the 5 treatment days.

  • GOS-E（Glasgow Outcome Scale - Extended）

    6 months

  • Changes in CRS-R subscale scores

    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

    Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.

  • +3 more secondary outcomes

Study Arms (2)

Sham comparator

SHAM COMPARATOR

Participants receive sham TI stimulation one session per day for 5 consecutive days

Device: sham TI

real TI stimulation

ACTIVE COMPARATOR

Participants receive real TI stimulation one session per day for 5 consecutive days

Device: real TI

Interventions

sham TIDEVICE

The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.

Sham comparator
real TIDEVICE

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.

real TI stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Mingzhou Brain Rehabilitation Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

  • 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: 37780965RESULT

  • 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: 39133053RESULT

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 16, 2025

First Posted

February 12, 2025

Study Start

January 20, 2025

Primary Completion

October 31, 2025

Study Completion

April 30, 2026

Last Updated

July 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)