NCT06515132 Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
| NCT ID | NCT06515132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Disorder of Consciousness |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-01-10 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
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.
Contact & Investigator
Xuehai Wu, Ph.D.
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Huashan Hospital, Fudan University
Frequently Asked Questions
Who can join the NCT06515132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Disorder of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515132 currently recruiting?
Yes, NCT06515132 is actively recruiting participants. Contact the research team at Wuxuehai2013@163.com for enrollment information.
Where is the NCT06515132 trial being conducted?
This trial is being conducted at Fuzhou, China, Changsha, China, Shanghai, China.
Who is sponsoring the NCT06515132 clinical trial?
NCT06515132 is sponsored by Huashan Hospital. The principal investigator is Xuehai Wu, Ph.D. at Department of Neurosurgery, Huashan Hospital, Fudan University. The trial plans to enroll 50 participants.