Actively Recruiting
Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Led by Huashan Hospital · Updated on 2025-01-07
50
Participants Needed
3
Research Sites
72 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
CONDITIONS
Official Title
Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients between the ages of 18 and 65, experiencing DOC for 3 months to 1 year following brain disease
- Diagnosis of DOC caused by traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction
- Stable cerebral anatomy without need for further cranioplasty or hydrocephalus shunt
- Patients in minimally conscious state meeting at least one of these: oriented response to pain, sustained eye tracking, purposeful movement, or understanding language/emotions
- Stable vital signs and consciousness: normal body temperature, stable spontaneous breathing without oxygen for at least 2 hours, no significant consciousness changes for at least 1 month
- Presence of short-latency responses (N20/P25) on somatosensory evoked potentials from the median nerve
- Written informed consent from legal guardians or representatives
You will not qualify if you...
- History of severe neurological or psychiatric disorders or other serious diseases before DOC onset
- Contraindications for surgery such as acute infections or clotting disorders
- Need for short-wave diathermy treatment preventing neurostimulation
- Hypoxic brain injury from suffocation, cardiac arrest, or respiratory arrest
- Brainstem hemorrhage
- Pregnant women
- Patients unwilling to cooperate with the research protocol despite requesting SCS implantation
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
2
Xiangya Hospital,Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
3
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
X
Xuehai Wu, Ph.D.
CONTACT
L
Lijian Lang, M.M.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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