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Micro-movements in Patients With Prolonged Disorders of Consciousness

Zhejiang University logo

Zhejiang University

Status

Enrolling

Conditions

Consciousness Disorders

Treatments

Diagnostic Test: micro-movement; electroencephalogram; MRI

Study type

Observational

Funder types

Other

Identifiers

NCT06406413
Micro-movement

Details and patient eligibility

About

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.

Full description

In accordance with the inclusion and exclusion criteria, a total of about 178 participants will be recruited, including about 89 confirmed cases of prolonged disorders of consciousness and 89 healthy control subjects (HCs). Utilizing the random split algorithm from the machine learning library sklearn, the dataset will be randomly divided into a training set (70%) and a testing set (30%). General information about the participants such as age, gender, time and location of injury, as well as medical history, family history, medication history, and surgical history will be collected.

Participants will undergo dual-person, multiple assessments using the CRS-R scale to evaluate auditory, visual, motor, speech responsiveness, communication, and arousal levels. Micro-movement changes in response to various emotional stimuli will be collected, along with EEG and MRI data.

Follow-up evaluations will be conducted on all enrolled patients using the CRS-R scale and the GOS scale, with a follow-up period of 6 months.

Enrollment

179 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

179 participants in 2 patient groups

DoC patients
Description:
patients with disorders of consciousness
Treatment:
Diagnostic Test: micro-movement; electroencephalogram; MRI
healthy controls
Description:
healthy participants matched by gender and age
Treatment:
Diagnostic Test: micro-movement; electroencephalogram; MRI

Trial contacts and locations

1

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Central trial contact

Benyan Luo; Zhuolin He

Data sourced from clinicaltrials.gov

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