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

Not Applicable

Recruiting

• Conditions: Disorders of Consciousness; Severe Brain Injury; Unresponsive Wakefulness Syndrome; Minimally Conscious State

• Registration Number: NCT06851156
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-26
• Study First Posted: 2025-02-28
• Last Update Submitted: 2025-04-06
• Study Start: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CRS-R total score changes	From enrollment to the end of treatment at 10 days	Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.

Secondary Outcome Measures

Name	Time	Method
Numbers of patients with improved consciousness	From enrollment to the end of treatment at 10 days
EEG changes	From enrollment to the end of treatment at 10 days	EEG power spectra, Connectivity and ABCD model, etc

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China