The Temporally Interfering in Patients with Disorders of Consciousness

NCT ID: NCT06822192

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Disorders of Consciousness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TI

Group Type EXPERIMENTAL

temporally interfering electrical stimulation

Intervention Type DEVICE

temporally interfering electrical stimulation

Interventions

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temporally interfering electrical stimulation

temporally interfering electrical stimulation

Intervention Type DEVICE

Eligibility Criteria

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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 70 years old; Informed consent was obtained from the patients' family members.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang, MD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Li Zhang

Role: CONTACT

+86-13732274598

References

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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.

Reference Type BACKGROUND
PMID: 37780965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39133053 (View on PubMed)

Other Identifiers

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TI-DOC

Identifier Type: -

Identifier Source: org_study_id

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