Observing micro-movements in patients with prolonged disorders of consciousness
Study of Micro-movements in Patients With Prolonged Disorders of Consciousness
This study is trying to see if tiny movements in patients with prolonged disorders of consciousness can help us understand their level of awareness and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 179 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Trial ID | NCT06406413 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate micro-movements in patients with prolonged disorders of consciousness using a neuropsychological paradigm model. It will assess the patients' levels of consciousness and classify them accurately while screening for cognitive-motor dissociation to enhance prognosis. Participants will undergo evaluations using the CRS-R scale, and their micro-movement responses to emotional stimuli will be recorded alongside EEG and MRI data. The study will involve approximately 178 participants, including both patients and healthy controls, with follow-up assessments over a six-month period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with consciousness disorders lasting more than 28 days following severe brain injury.
Not a fit: Patients with locked-in syndrome or those with contraindications for EEG or MRI examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and prognosis of cognitive function in patients with disorders of consciousness.
How similar studies have performed: While the approach of monitoring micro-movements in this context is relatively novel, similar studies have shown promise in understanding consciousness disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the CRS-R scale to meet the criteria for VS or MCS; 2. Aged between 18 and 80 years; 3. Stable vital signs; 4. Voluntary participation of family members with signed informed consent; 5. Good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs. Exclusion Criteria: 1. Locked-in syndrome; 2. Contraindications for EEG examination; 3. Contraindications for MRI scanning, such as the presence of internal metallic implants; 4. Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.
Where this trial is running
Hanzhou, Zhejiang
- First Affiliated Hospital,Zhejiang University — Hanzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Zhuolin He
- Email: hezhuolin@zju.edu.cn
- Phone: 15990049962
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.