Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
NCT ID: NCT06515132
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-10
2026-05-30
Brief Summary
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Detailed Description
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In recent years, spinal cord stimulation (SCS) has emerged as a cutting-edge and extensively researched modality for arousal therapy. SCS is a form of neuromodulation therapy primarily utilized for intractable pain, diabetic neuropathy, and muscle spasticity, the therapeutic efficacy of the SCS is both significant and safe. Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC, these findings are currently limited to small sample reports. Therefore, this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC, thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SCS group
SCS stimulation therapy is initiated 1 week post-surgery, which is administered continuously for a duration of 6 months.
SCS Stimulation
Participants will accept the SCS stimulus for six months
Sham group
Sham stimulation therapy is initiated 1 week post-surgery, and SCS stimulation therapy is initiated 3 months post-surgery, which is stimulated continuously for a duration of 3 months.
Sham Stimulation
Sham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery
Interventions
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SCS Stimulation
Participants will accept the SCS stimulus for six months
Sham Stimulation
Sham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Huashan Hospital
OTHER
Responsible Party
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Xuehai Wu
Deputy Director of Shanghai Neurosurgical Emergency Center
Principal Investigators
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Xuehai Wu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Huashan Hospital, Fudan University
Locations
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Xiangya Hospital,Central South University
Changsha, Hunan, China
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Peisen Yao, Ph.D.
Role: primary
Zhongyi Sun, Ph.D.
Role: primary
References
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Other Identifiers
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KY2024-752
Identifier Type: -
Identifier Source: org_study_id
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