NCT06406413 Micro-movements in Patients With Prolonged Disorders of Consciousness
| NCT ID | NCT06406413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Consciousness Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 179 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 179 participants in total. It began in 2024-05-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the micro-movements in patients with prolonged disorders of consciousness. The main questions it aims to answer are: Use the neuropsychological paradigm model to monitor micro-movements, assess the patient's remaining level of consciousness and accurately classify it; screen out patients with cognitive-motor dissociation to improve the prognosis of cognitive function; explore the remaining brain function of patients with chronic disorders of consciousness and promote relevant study of neural mechanisms. Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-movement changes in response to various emotional stimuli will be captured, along with the collection of EEG and MRI data. Follow-up evaluations will be conducted using the CRS-R scale and GOS scale, with a follow-up period of 6 months.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06406413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Consciousness Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06406413 currently recruiting?
Yes, NCT06406413 is actively recruiting participants. Contact the research team at hezhuolin@zju.edu.cn for enrollment information.
Where is the NCT06406413 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT06406413 clinical trial?
NCT06406413 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 179 participants.