Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness

Xijing Hospital10 enrolled

Overview

The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Disorders of Consciousness Severe Brain Injury Unresponsive Wakefulness Syndrome Minimally Conscious State

Interventions

tTISDEVICE

CM-pf tTIS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria. Exclusion Criteria: * patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.

Locations (2)

Xijing Hospital

Xi'an, Shaanxi, China

NOT_YET_RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

CRS-R total score changes

Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.

Time frame: From enrollment to the end of treatment at 10 days

Secondary Outcomes

Numbers of patients with improved consciousness

Time frame: From enrollment to the end of treatment at 10 days

EEG changes

EEG power spectra, Connectivity and ABCD model, etc

Time frame: From enrollment to the end of treatment at 10 days

Central Contacts

Gengyao Hu

CONTACT

86-15399059833 304517021@qq.com

Data from ClinicalTrials.gov

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