Vegetative StateNCT02832492
The Prognostic Value of Pupil Near Response in UWS Patients
An observational study of Vegetative State, run by Wentao Zeng.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 85 years
- Conditions the study is for
- Vegetative State
- What is being tested?
- pupil near response
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2015to 10 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who has been diagnosed as unresponsive wakefulness syndrome by CRS-R before this study.
Who may be able to join
- 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.
Who cannot join
- nystagmus and drooping eyelids
- unstable vital signs
- under sedation during PNR test.
About this study
Official title: Does Pupil Near Response Have Prognostic Value in Patients With Unresponsive Wakefulness Syndrome?
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.
Read the detailed description
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.
- Conditions
- Vegetative State
- Being tested
- pupil near response
- Keywords
- disorders of consciousness, unresponsive wakefulness syndrome, pupil near response, prognosis of consciousness recovery
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pupil near responseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PNR+ | Patients who will show pupil near response during PNR assessment. Receives: Behavioral: pupil near response | |
| PNR- | Patients who will not show pupil near response during PNR assessment. Receives: Behavioral: pupil near response |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Greater proportion in PNR+ group suggests PNR can correct misdiagnosis caused by lesions on motor systems thus is applicable to patients without motor function
Measured: 3 months after pupil near response assessment in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start29 Oct 2015
- Primary completion10 Feb 2016
- Study completion10 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vegetative StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wentao Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wentao Zeng, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832492
- Sponsor's protocol ID
- 2015/1030/B
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2016
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pupil Near Response Have Prognostic Value in Patients With Unresponsive Wakefulness Syndrome?
- ClinicalTrials.gov ID
- NCT02832492
- Acronym / sponsor ID
- 2015/1030/B
- Conditions
- Vegetative State
- Keywords
- disorders of consciousness, unresponsive wakefulness syndrome, pupil near response, prognosis of consciousness recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wentao ZengUniversity, hospital or other
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 10 Feb 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNR+ | – | Behavioral: pupil near responsePatients who will show pupil near response during PNR assessment. |
| PNR- | – | Behavioral: pupil near responsePatients who will not show pupil near response during PNR assessment. |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who has been diagnosed as unresponsive wakefulness syndrome by CRS-R before this study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- nystagmus and drooping eyelids
- unstable vital signs
- under sedation during PNR test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pupil near response | Behavioural | PNR+, PNR- |
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
Greater proportion in PNR+ group suggests PNR has prognostic value to DOC patients thus has relationship with consciousness
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vegetative State, run by Wentao Zeng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.