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

April 6, 2025 updated by: Xijing Hospital

An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Temporal Interference Stimulation
tTIS is applied over the bilateral CM-pf for 10 days, once a day.
Device: tTIS
CM-pf tTIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRS-R total score changes
Time Frame: 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.
From enrollment to the end of treatment at 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG changes
Time Frame: From enrollment to the end of treatment at 10 days
EEG power spectra, Connectivity and ABCD model, etc
From enrollment to the end of treatment at 10 days
Numbers of patients with improved consciousness
Time Frame: From enrollment to the end of treatment at 10 days
From enrollment to the end of treatment at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: wen Jiang, phD, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242231jiangwen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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