RecruitingNot ApplicableNCT06515132

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

Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail

Sponsor

Huashan Hospital

Enrollment

50 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.

Min Age: 18 YearsMax Age: 65 Years

Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease.
Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction.
Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt.
Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying).
The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and respiratory stability without oxygen supplementation for at least 2 hours); there is no significant change in 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.

Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;
Patients with contraindications for surgery, such as acute infections or coagulation disorders;
Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;
Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;
Patients with brainstem hemorrhage;
Pregnant women;
Patients who voluntarily request SCS implantation but are unwilling to cooperate with the research protocol;
Participants in other clinical trials.