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Clinical Trials in China / NCT06896279
Recruiting Not applicable

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

NCT06896279 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2025-04-21
Last updated
2025-12-16

Condition(s) studied

Disorder of ConsciousnessTemporal Interference Stimulation

Investigational drug(s) / intervention(s)

TI StimulationSham Stimulation

TI Stimulation: Participants will accept the TI stimulus for one month

Sham Stimulation: Participants will accept the sham TI stimulus for one month

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender; * Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more; * Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination; * Written informed consent obtained from the patient's family members in advance. Exclusion Criteria: * Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney; * Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals; * Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future; * Pregnant women; * Those who have participated in other drug or device clinical trials; * Patients with poorly controlled epilepsy in the recent period; * Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site; * Those currently taking medications prone to inducing epilepsy, such as quinolone drugs; * Those with intracranial infections, intracranial tumors, or metallic objects within the cranium; * Those allergic to electrode gel or adhesives; * Those with implanted electronic devices within the body; * Those with severe cardiac disorders and those equipped with cardiac pacemakers.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University Shanghai Shanghai Municipality Recruiting
Department of Neurosurgery, Huashan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06896279 on ClinicalTrials.gov ↗ ← All trials in China