NCT06097013

Brief Summary

The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2022Nov 2026

Study Start

First participant enrolled

April 13, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

July 22, 2024

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

October 18, 2023

Last Update Submit

July 19, 2024

Conditions

Disorder of Consciousness

Keywords

Brain Function Test

Outcome Measures

Primary Outcomes (5)

  • Change from Coma recovery scale-revised

    CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness

    Within 24 hours of enrollment

  • Change from the p300 in electroencephalogram

    Assessment the p300 in event related potential(ERP)

    Assessment within 24 hours before, and 1 hour after TMS treatment

  • Change from resting-state in electroencephalogram

    Assessment the spectral power and coherence by in resting-state EEG

    Assessment within 24 hours before, and 1 hour after TMS treatment

  • Change from TEP in electroencephalogram

    Assessment the TMS Evoked Potential(TEP)

    Assessment within 24 hours before, and 1 hour after TMS treatment

  • Change from PCI in electroencephalogram

    Assessment the perturbational complexity index(PCI) in TMS-EEG

    Assessment within 24 hours before, and 1 hour after TMS treatment

Secondary Outcomes (1)

  • Change from ROI in neuroimage techniques-PET

    Assessment within 24 hours before ,and 1 hour after TMS treatment

Study Arms (2)

Prolonged disorders of consciousness

Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria

Other: Routine clinical rehabilitation

Acute disorders of consciousness

Admission criteria for patients with acute disorders of consciousness Inclusion Criteria

Other: Routine clinical rehabilitation

Interventions

Routine clinical rehabilitationOTHER

Routine clinical rehabilitation

Acute disorders of consciousnessProlonged disorders of consciousness

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

prolonged disorders of consciousness and acute disorders of consciousness

You may qualify if:

  • Age 14-60 years;
  • In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
  • Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
  • right-handed；
  • The patient's family members signed the informed consent form;

You may not qualify if:

  • The history of mental illness and a history of hearing impairment;
  • Intracranial arterial clamp, pacemaker and other metal implants;
  • During the experiment, sedatives and other drugs that affect the excitability of the cortex;
  • The presence of uncontrolled seizures or involuntary movements;
  • Admission criteria for patients with acute disorders of consciousness
  • (1)Age 14-60 years; (2）Meets diagnostic criteria for coma recognized in international studies； (3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness; (5) right-handed； (6)The patient's family members signed the informed consent form;
  • The history of mental illness and a history of hearing impairment;
  • Intracranial arterial clamp, pacemaker and other metal implants;
  • During the experiment, sedatives and other drugs that affect the excitability of the cortex;
  • The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;
  • No spontaneous breathing;
  • Status Epilepticus;
  • Need emergency neurosurgical treatment can not cooperate with the examination;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu hospitial, capical medical university

Beijing, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

April 13, 2022

Primary Completion

August 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

July 22, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)