NCT06896279 Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
| NCT ID | NCT06896279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Disorder of Consciousness |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-04-21 with a primary completion date of 2026-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
Eligibility Criteria
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.
Contact & Investigator
Xuehai Wu, Ph.D.
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Huashan Hospital, Fudan University
Frequently Asked Questions
Who can join the NCT06896279 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Disorder of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896279 currently recruiting?
Yes, NCT06896279 is actively recruiting participants. Contact the research team at Wuxuehai2013@163.com for enrollment information.
Where is the NCT06896279 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06896279 clinical trial?
NCT06896279 is sponsored by Huashan Hospital. The principal investigator is Xuehai Wu, Ph.D. at Department of Neurosurgery, Huashan Hospital, Fudan University. The trial plans to enroll 20 participants.