Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
Pupillometry
1 other identifier
observational
300
1 country
1
Brief Summary
The pupilometer determines the alteration of the pupil diameter after a defined light stimulus. In this study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during daily neurological routine examinations. The values are compared to outcomes resulting from pupilometer measurements done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 12, 2019
September 1, 2019
4 years
December 19, 2016
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of delayed cerebral ischemia (DCI)
DCI is defined as the development of new focal neurological signs and/or deterioration in level of consciousness, lasting for more than 1 h, or the appearance of new infarctions on CT or MRI.
21 days
Number of perfusion deficiency
21 days
Secondary Outcomes (3)
Transcranial Doppler (TCD) -fluency increase [cm/s]
21 days
Digital subtraction angiography (DSA)
day 7 ± 2 d
Glasgow Outcome Score (GOS)
after 3 and 6 month
Study Arms (2)
Control group
The control group implies patients with non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The pupilometer data are once collected during ambulant routine examination. The patients do not undergo any further study related examinations.
Treatment group
The treatment group implies patients with an acute cerebral disease ensured by CT, MRI or spinal tap. Pupillometry measurements are done during neurological routine examinations. Generally, during the initial diagnosis examination, followed by daily routine measurements and after 3 and 6 month upon hospital discharge.
Interventions
Device to measure change in pupil diameter due to a defined light stimulus.
Eligibility Criteria
The study includes male and female patients suffering from a acute (treatment group) or non-acute (control group) cerebral disease with a minimum age of 18 years.
You may qualify if:
- male or female patient, age ≥ 18 years
- signed consent
- treatment group:
- patient with acute, cerebral disease verified by CT, MRI or spinal tap
- control group
- patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms
You may not qualify if:
- female or male patient aged \< 18 years
- absent of signed consent
- persons who have a dependent or working relationship with the sponsor or investigator
- persons who are sheltered in an institution by juridical or governmental order
- concurrent participation in an other clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Related Publications (7)
Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
PMID: 21748035BACKGROUNDCiurea AV, Palade C, Voinescu D, Nica DA. Subarachnoid hemorrhage and cerebral vasospasm - literature review. J Med Life. 2013 Jun 15;6(2):120-5. Epub 2013 Jun 25.
PMID: 23904869BACKGROUNDCocker KD, Moseley MJ, Stirling HF, Fielder AR. Delayed visual maturation: pupillary responses implicate subcortical and cortical visual systems. Dev Med Child Neurol. 1998 Mar;40(3):160-2. doi: 10.1111/j.1469-8749.1998.tb15440.x.
PMID: 9566651BACKGROUNDFountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.
PMID: 16960298BACKGROUNDRowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264.
PMID: 22879655BACKGROUNDToi H, Matsumoto N, Yokosuka K, Matsubara S, Hirano K, Uno M. Prediction of cerebral vasospasm using early stage transcranial Doppler. Neurol Med Chir (Tokyo). 2013;53(6):396-402. doi: 10.2176/nmc.53.396.
PMID: 23803618BACKGROUNDLarson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.
PMID: 27329287BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerrit Alexander Schubert, Prof.
Uniklinik RWTH Aachen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- apl. Prof. Dr. med. Gerrit Alexander Schubert
Study Record Dates
First Submitted
December 19, 2016
First Posted
December 21, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
September 12, 2019
Record last verified: 2019-09