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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TI Stimulation
  • Sham Stimulation

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Huashan Hospital

Lead sponsor

Shanghai First Rehabilitation Hospital

Collaborator