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)
Effective rate of awakening — Stimulation for 1 month The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) Vegetative state(VS) recover to consciousness level of MCS- or higher; c) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication).
Trial sites (2)
Facility
City
Region
Status
Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University
Shanghai
Shanghai Municipality
Recruiting
Department of Neurosurgery, Huashan Hospital, Fudan University
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.
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