Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation

Inclusion Criteria:

• Male and female patients between the ages of 18 and 65, experiencing DOC for aduration ranging from 3 months to 1 year following brain disease.

• Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensiveintracerebral hemorrhage, or severe cerebral infarction.

• Patients exhibiting stable cerebral anatomy and no need for further cranioplasty orhydrocephalus shunt.

• Patients in MCS, who fulfill at least one of the following criteria: ① Demonstratingan oriented response to noxious stimuli; ② Exhibiting sustained eye trackingbehavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of languageor emotions and actions (often observed in specific environments such as whenhearing family members crying).

• The vital signs and state of consciousness are stable: normal body temperature, thespontaneous breathing is stable (minimal sputum production and respiratory stabilitywithout oxygen supplementation for at least 2 hours); there is no significant changein the level of consciousness for at least 1 month and more.

• Presence of short-latency responses (N20/P25) on somatosensory evoked potentials (SEP) recorded from the median nerve in the upper limbs.

• Written informed consent obtained from legal guardians or representatives.

Exclusion Criteria:

• Patients with a history of severe neurological or psychiatric disorders, or othersignificant diseases impacting prognosis prior to the onset of DOC;

• Patients with contraindications for surgery, such as acute infections or coagulationdisorders;

• Patients who require short-wave diathermy treatment and are unable to undergoneurostimulation;

• Patients with hypoxic brain injury due to suffocation, cardiac arrest, orrespiratory arrest;

• Patients with brainstem hemorrhage;

• Pregnant women;

• Patients who voluntarily request SCS implantation but are unwilling to cooperatewith the research protocol;

• Participants in other clinical trials.