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Recruiting NCT06851156

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

No phase Interventional Disorders of Consciousness Severe Brain Injury Unresponsive Wakefulness Syndrome Minimally Conscious State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tTIS.
Who it may be relevant to
Registry conditions: Disorders of Consciousness, Severe Brain Injury, Unresponsive Wakefulness Syndrome, Minimally Conscious State. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device tTIS
    CM-pf tTIS

Primary outcome measures

  • CRS-R total score changes [Time frame: From enrollment to the end of treatment at 10 days]
Secondary outcome measures (2)
  • Numbers of patients with improved consciousness [Time frame: From enrollment to the end of treatment at 10 days]
  • EEG changes [Time frame: From enrollment to the end of treatment at 10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Xijing Hospital — Xi'an
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT06851156 · KY20242231jiangwen

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗