RecruitingNot ApplicableNCT06896279

Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders


Sponsor

Huashan Hospital

Enrollment

20 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive brain stimulation technique called temporal interference stimulation (TIS) to help improve awareness and responsiveness in patients who are in a vegetative state or minimally conscious state after severe brain injury. TIS uses electrical currents applied to the scalp to stimulate deep brain regions without surgery. Researchers want to find out if this approach can help patients recover consciousness. **You may be eligible if...** - You are between 18 and 75 years old - You have been in a vegetative state or minimally conscious state for at least 28 days - Your vital signs are stable and you are breathing on your own (or with a tracheostomy that does not use a metal tube) - You are not in active rehabilitation for disorders of consciousness **You may NOT be eligible if...** - You have a metal implant in your head (such as a metal skull plate, cochlear implant, or deep brain stimulator) - You have a pacemaker or other implanted electronic device - You have a history of seizures or epilepsy - You have active skin infections or wounds on the scalp where the electrodes would be placed - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETI Stimulation

Participants will accept the TI stimulus for one month

PROCEDURESham Stimulation

Participants will accept the sham TI stimulus for one month


Locations(2)

Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06896279


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