Clinical Trial: Pupil Near Response in UWS Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pupil Near Response - A Promising Prognostic Index in Patients With Unresponsive Wakefulness Syndrome

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.

Detailed Summary:

PNR assessments will be conducted in patients with Unresponsive Wakefulness Syndrome (UWS) diagnosed by the Coma recovery scale-revised (CRS-R).An objective index,the ratio of pupillary constriction (pupil diameter change after a stimulus presentation divided by the resting state pupil diameter) will be used as the measure of PNR's presence (positive results indicate the presence of PNR,whereas negative results indicate the absence of PNR).According to the presence of PNR,patients will be divided into 2 groups,one includes patients who show PNR during the PNR assessment (PNR+),the other includes patients who fail to show PNR during the PNR assessment(PNR-).3 months later,a follow-up will be conducted to obtain their prognosis in the form of another CRS-R assessment.Patients diagnosed as Minimally Conscious State (MCS) will be considered as favourable prognosis,patients diagnosed as UWS will be considered as unfavourable prognosis.Their prognosis difference will then be compared to see PNR's effect on their prognosis (consciousness recovery). And for they couldn't show conscious visual behaviors (visual behaviors in CRS-R which indicate MCS) in the first CRS-R,their difference between visual prognosis (difference between each group's proportion of patients showing conscious visual behavior diagnosed by CRS-R in the follow up) will be compared to see PNR's capability to predict prognosis in patients without voluntary eye movements (conscious visual behaviors in CRS-R require voluntary eye movements).

Researchers expect to see the PNR+ group have better prognosis in both comparison.

Sponsor: Wentao Zeng

Current Primary Outcome: Each group's proportion of MCS patients diagnosed by CRS-R in the follow up [ Time Frame: 3 months after pupil near response assessment in this study ]

Original Primary Outcome: Each group's proporation of MCS patients diagnosed by CRS-R in the follow up [ Time Frame: 3 months after pupil near response test in this study ]

Current Secondary Outcome: Each group's proportion of recovery of conscious visual function diagnosed by visual subscale of CRS-R in the follow up [ Time Frame: 3 months after pupil near response assessment in this study ]

Original Secondary Outcome: Each group's proporation of recovery of conscious visual function diagnosed by visual subscale of CRS-R in the follow up [ Time Frame: 3 months after pupil near response test in this study ]

Information By: Hangzhou Normal University

Dates:
Date Received: July 11, 2016
Date Started: October 29, 2015
Date Completion:
Last Updated: April 23, 2017
Last Verified: April 2017