Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT06515132
Eligibility Criteria:
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: 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.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06515132
Study Brief:
Protocol Section:
NCT06515132