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

Launched by HUASHAN HOSPITAL · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of spinal cord stimulation (SCS) to see if it can help patients who are in a disorder of consciousness (DOC). DOC can happen after severe brain injuries, and it affects a person's awareness and ability to respond to their surroundings. The trial aims to find out if SCS can improve both the safety and effectiveness of treatment for these patients.

To be eligible for this trial, participants must be between 18 and 65 years old and have been in a DOC state for 3 months to 1 year after a brain-related issue. They should also show some signs of awareness, like responding to painful stimuli or tracking objects with their eyes. The study is open to all genders, and participants will be carefully monitored throughout the process. If you or someone you know might be interested in participating, it’s important to discuss this with a healthcare provider to understand the potential benefits and risks.

Gender

ALL

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.