The Temporally Interfering in Patients with Disorders of Consciousness

Zhejiang Provincial People's Hospital

Status: Not yet enrolling

Conditions: Disorders of Consciousness

Treatments: Device: temporally interfering electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06822192

TI-DOC

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

TI

Experimental group

Treatment:

Device: temporally interfering electrical stimulation