An observational study in Vegetative State, sponsored by Wentao Zeng. Completed. Open to participants aged 6 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Wentao Zeng · Observational
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.
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.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 31 observational studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →This is the only study on the registry with Wentao Zeng as lead sponsor.
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patients who has been diagnosed as unresponsive wakefulness syndrome by CRS-R before this study.
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Exclusion Criteria:
Patients who will show pupil near response during PNR assessment.
Behavioral: pupil near response
Patients who will not show pupil near response during PNR assessment.
Behavioral: pupil near response
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
Time frame: 3 months after pupil near response assessment in this study
Each group's proportion of recovery of conscious visual function diagnosed by visual subscale of CRS-R in the follow up
Greater proportion in PNR+ group suggests PNR can correct misdiagnosis caused by lesions on motor systems thus is applicable to patients without motor function
Time frame: 3 months after pupil near response assessment in this study
No study locations are listed for this record.
Ran from Oct 2015 to primary completion in Feb 2016, 3 months.
Of 16 observational studies under Persistent Vegetative State, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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