Status:
RECRUITING
Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Shanghai First Rehabilitation Hospital
Conditions:
Disorder of Consciousness
Temporal Interference Stimulation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
Detailed Description
Based on the central loop hypothesis, deep brain stimulation (DBS) represents a commonly utilized neuro-modulation stimulation technology for disorders of consciousness (DOC). It was initially employe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 17 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06896279
Start Date
April 21 2025
End Date
May 17 2026
Last Update
December 16 2025
Active Locations (2)
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1
Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200000
2
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000