Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
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.
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;
Parallel
TI Stimulation
Procedure/SurgeryParticipants will accept the TI stimulus for one month
Sham Stimulation
Procedure/SurgeryParticipants will accept the sham TI stimulus for one month
Effective rate of awakening
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).
The difference of CRS-R scale relative to baseline between TI group and sham group
The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.
The difference of Simplified Evaluation of CONsciousness Disorders (SECONDs) scale relative to baseline between TI group and sham group
The SECONDs is a fast tool to assess consciousness in brain-injured patients. The minimum score is 0 and the maximum is 8, higher scores mean a better outcome.
The difference of modified Ashworth scale relative to baseline between TI group and sham group
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The minimum grade is 0 and the maximum is 4, higher scores mean a worse outcome.
The difference of Nociception Coma Scale-Revised (NCS-R) scale relative to baseline between TI group and sham group
The NCS-R was developed to help assess pain in patients with disorders of consciousness (DOC). Several studies have shown its sensitivity in assessing response to acute noxious stimuli. The minimum score is 0 and the maximum is 12, higher scores mean a better outcome.
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Shanghai First Rehabilitation Hospital
Collaborator
