The Temporally Interfering in Patients with Disorders of Consciousness

NCT06822192 | Not Yet Recruiting DMC

• 1 other identifier: TI-DOC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Disorders of Consciousness

Outcome Measures

Primary Outcomes (2)

• CRS-R (Coma Recovery Scale-revised)

  The CRS-R scale, with scores ranging from 0 to 23, can help to distinguish unresponsive arousal syndrome from micro-conscious states.

  One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus

• Adverse reactions

  Any adverse events related to the study

  One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus

Secondary Outcomes (3)

• EEG

  One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus

• fNIRS（functional near-infrared spectroscopy）

  One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus

• GOS-E（Glasgow Outcome Scale - Extended）

  2 weeks, 1 month, and 3 months after the end of stimulation

Study Arms (1)

TI

EXPERIMENTAL

Device: temporally interfering electrical stimulation

Interventions

temporally interfering electrical stimulation DEVICE

temporally interfering electrical stimulation

TI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 70 years old; Informed consent was obtained from the patients' family members.

You may not qualify if:

• Previous history of neurological or psychiatric disorders; Previous history of traumatic brain 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

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: 37780965 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Li Zhang

CONTACT

+86-13732274598; zhangli0407@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: February 20, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share