The Prognostic Value of Pupil Near Response in UWS Patients

NCT02832492 | Completed

• 1 other identifier: 2015/1030/B
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous studies suggest that the stimulus of pupil near response (PNR) may be a conscious perception of a blurred image. Moreover, PNR is a reflex that can be objectively observed and with no motor output, suggesting it might be a more convenient index for consciousness evaluation and consciousness recovery in patients with disorders of consciousness (DOC). We thus hypothesized that PNR+ patients (patients show PNR during the assessment) would have better prognosis than PNR- patients (patients fail to show PNR during the assessment).Based on this hypotheis, researchers will assess pupil near response in patients with unresponsive wakefulness syndrome (UWS) and compare the prognosis difference between PNR+ patients and PNR- patients to assess its prognosis value.

Conditions

Vegetative State

Keywords

disorders of consciousness; unresponsive wakefulness syndrome; pupil near response; prognosis of consciousness recovery

Outcome Measures

Primary Outcomes (1)

• Each group's proportion of MCS patients diagnosed by CRS-R in the follow up

  Greater proportion in PNR+ group suggests PNR has prognostic value to DOC patients thus has relationship with consciousness

  3 months after pupil near response assessment in this study

Secondary Outcomes (1)

• Each group's proportion of recovery of conscious visual function diagnosed by visual subscale of CRS-R in the follow up

  3 months after pupil near response assessment in this study

Study Arms (2)

PNR+

Patients who will show pupil near response during PNR assessment.

Behavioral: pupil near response

PNR-

Patients who will not show pupil near response during PNR assessment.

Behavioral: pupil near response

Interventions

pupil near response BEHAVIORAL

PNR+; PNR-

Eligibility Criteria

• Age: 6 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who has been diagnosed as unresponsive wakefulness syndrome by CRS-R before this study.

You may qualify if:

• unresponsive wakefulness syndrome (diagnosed by CRS-R)
• normal or corrected to normal vision before the incidence (myopia did not exceed 300 degrees Fahrenheit, farsightedness was less than + 2.00 d)
• positive pupil light reflex.

You may not qualify if:

• nystagmus and drooping eyelids
• unstable vital signs
• under sedation during PNR test.

Sponsors & Collaborators

• Wentao Zeng: lead

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master degree candidate

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: October 29, 2015
• Primary Completion: February 10, 2016
• Study Completion: February 10, 2016
• Last Updated: August 4, 2022

Record last verified: 2022-08