The vegetative state: prevalence, misdiagnosis, and treatment limitations.
Willemijn S van Erp, Jan C M Lavrijsen, Pieter E Vos...
https://pubmed.ncbi.nlm.nih.gov/25528282Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06515132
Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trial
Led by Huashan Hospital · Updated on 2025-01-07
50
Participants Needed
3
Research Sites
21 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
Researchers are evaluating the effectiveness and safety of spinal cord stimulation (SCS) in patients with disorders of consciousness (DOC), which include coma, unresponsive wakefulness syndrome, and minimally conscious state following acute brain injuries. Current treatments for DOC are limited, with only a few showing promising results. This multicenter randomized controlled trial aims to provide strong evidence on SCS as a potential therapy to promote arousal in these patients and to help standardize its clinical use. Participants will be randomly assigned to two groups. One group will receive continuous SCS stimulation starting one week after surgery for six months. The other group will receive sham stimulation for the first three months after surgery and then begin SCS stimulation for the following three months. This design allows comparison between early and delayed SCS treatment over a six-month period. During the trial, participants will be monitored through various assessments including consciousness rating scales and motor function evaluations at multiple time points up to six months post-surgery. Researchers will track awakening rates and recovery progress using standardized clinical scales. Safety and effectiveness will be closely observed throughout, with the total study participation lasting up to six months after surgery.
CONDITIONS
Brief Title
Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients between the ages of 18 and 65
- Experiencing disorder of consciousness for 3 months to 1 year following brain disease
- Diagnosed with disorder of consciousness caused by traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction
- Stable cerebral anatomy with no need for further cranioplasty or hydrocephalus shunt
- Patients in minimally conscious state showing at least one of: oriented response to noxious stimuli, sustained eye tracking, purposeful movements, or comprehension of language or emotions
- Stable vital signs and consciousness state for at least 1 month, including normal body temperature and stable spontaneous breathing without oxygen support for at least 2 hours
- Presence of short-latency responses on somatosensory evoked potentials from the median nerve
- Written informed consent obtained from legal guardians or representatives
You will not qualify if you...
- History of severe neurological or psychiatric disorders or other diseases affecting prognosis before disorder of consciousness onset
- Contraindications for surgery such as acute infections or coagulation disorders
- Need for short-wave diathermy treatment incompatible with neurostimulation
- Hypoxic brain injury caused by suffocation, cardiac arrest, or respiratory arrest
- Brainstem hemorrhage
- Pregnant women
- Patients unwilling to cooperate with the research protocol despite requesting spinal cord stimulation implantation
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 week
Participants undergo surgery for spinal cord stimulation implantation and receive immediate post-operative care.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive spinal cord stimulation therapy or sham stimulation according to their assigned group to promote arousal.
Regular visits over 6 months for stimulation and assessments
Follow-up
Duration - Up to 6 months post-treatment
Participants are monitored for effectiveness and safety of spinal cord stimulation after the treatment period.
Periodic assessments depending on recovery progress
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
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Research Team
X
Xuehai Wu, Ph.D.
L
Lijian Lang, M.M.
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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