Analyzing brain activity patterns in patients with prolonged disorders of consciousness
Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography
This study is testing how brain activity changes in patients with prolonged disorders of consciousness before and after they receive a spinal cord stimulator while under anesthesia, compared to healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06157008 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the differences in brain activity as measured by polysomnography (PSG) between healthy volunteers and patients with prolonged disorders of consciousness (pDoC). It will assess brain network changes in pDoC patients before and after the insertion of a spinal cord electric stimulator under general anesthesia. The study will also compare PSG results in pDoC patients before and after spinal cord stimulation to identify characteristic changes in brain networks. The goal is to enhance understanding of brain function in these patients and the effects of anesthesia.
Who should consider this trial
Good fit: Ideal candidates include native Chinese adults aged 18-65 with prolonged disorders of consciousness following acquired brain injury.
Not a fit: Patients with significant brain structure damage or severe systemic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of brain function in patients with disorders of consciousness, potentially leading to better treatment strategies.
How similar studies have performed: While there have been studies on brain activity in pDoC patients, this specific approach using polysomnography and spinal cord stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria of health volunteer group: 1. Aged 18-65, native Chinese 2. No history of sleep apnea 3. No history of insomnia 4. Volunteer to participate in this study and obtain informed consent. * Inclusion criteria of pDoC group: 1. Aged 18-65, native Chinese 2. pDoC after acquired brain injury 3. The spinal electric stimulator was implanted under general anesthesia 4. Obtain informed consent. * Exclusion Criteria: 1. Healthy volunteers took hypnotic drugs 72 hours before the study 2. Continuous sedation treatment was carried out within 72 hours before the study 3. The integrity of brain structures such as open head injury and brain parenchyma resection 4. Intracranial compliance decreased due to hydrocephalus 5. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons 6. Known or suspected to have serious heart, lung and kidney dysfunction 7. Allergic history of sedative drugs 8. Combined with other mental or nervous system diseases 9. Other reasons are not suitable for this study.
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, M.D
- Email: ruquan.han@ccmu.edu.cn
- Phone: 8610-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.