Status:
RECRUITING
Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Xiangya Hospital of Central South University
First Affiliated Hospital of Fujian Medical University
Conditions:
Disorder of Consciousness
Spinal Cord Stimulation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
Detailed Description
Disorder of Consciousness (DOC) is a highly significant and concerning consequence that frequently ensues various acute brain injuries. The DOC encompasses coma, unresponsive wakefulness syndrome (UWS...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06515132
Start Date
January 10 2025
End Date
May 30 2026
Last Update
January 7 2025
Active Locations (3)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000
2
Xiangya Hospital,Central South University
Changsha, Hunan, China, 410000
3
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000