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โ† Trials
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Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation

RecruitingNAAges 18 Years - 65 YearsAllHuashan Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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: โ‘  Demonstrating an oriented response to noxious stimuli; โ‘ก Exhibiting sustained eye tracking behavior; โ‘ข Displaying purposeful movements; โ‘ฃ 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. Exclusion Criteria: * 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.
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What it tests

  • SCS Stimulation
  • Sham Stimulation
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Where

3 sites
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Xiangya Hospital,Central South University
Changsha, China
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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