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
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
Researchers are evaluating the effectiveness and safety of spinal cord stimulation (SCS) for patients who have disorders of consciousness (DOC), which can occur after serious brain injuries. DOC includes conditions like coma, unresponsive wakefulness syndrome, and minimally conscious state. Current treatments such as medications, oxygen therapy, neuromodulation, physical rehabilitation, and acupuncture offer limited success, with only amantadine and transcranial direct current stimulation showing some benefit. This trial aims to provide strong evidence on how well SCS can help patients regain consciousness and improve care standards. The study involves two groups of participants. One group will receive continuous SCS treatment for six months, while the other group will undergo sham stimulation for the first three months after surgery and then begin SCS from the fourth month onward. SCS is a neuromodulation technique previously used for pain and muscle issues, and this trial tests its use in awakening patients with DOC. The study design is a multicenter, double-blind, randomized controlled trial to ensure reliable results. Participants will be monitored for the effectiveness of awakening with SCS stimulation after three months of treatment. They must be between 18 and 65 years old and have stable vital signs and brain anatomy. Researchers will evaluate their neurological responses, consciousness levels, and overall safety throughout the study. The total participation includes careful observation and follow-up to assess both benefits and any potential risks during the six-month intervention period.
CONDITIONS
Official 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 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
1
2
3
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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Sozaburo Hara, Hege Andresen, Ole Solheim...
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