Clinical trial NCT02999659: Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
Official title: Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pupillary Function, Abnormal
Cerebral Aneurysm
Keywords: pupillometry
autonomous nerve system
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The pupilometer determines the alteration of the pupil diameter after a defined light stimulus providing information of the autonomic nerve system. The result collecting from pupillometry is objective and more precise than the subjective-visual evaluation of the pupil and its reactivity.

In this observational study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during neurological routine examinations. The first measurement is done during the initial diagnosing examination, followed by daily measurements and ending with measurements after 3 and 6 month upon hospital discharge. The values are compared to standard values resulting from pupilometer measurements done on patients having non-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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of delayed cerebral ischemia (DCI)
timeFrame: 21 days
measure: Number of perfusion deficiency
timeFrame: 21 days
Secondary outcomes:
measure: Transcranial Doppler (TCD) -fluency increase [cm/s]
timeFrame: 21 days
measure: Digital subtraction angiography (DSA)
timeFrame: day 7 ± 2 d
measure: Glasgow Outcome Score (GOS)
timeFrame: after 3 and 6 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
state: Nordrhein-Westfalen
Study officials:
affiliation: Uniklinik RWTH Aachen
name: Gerrit Alexander Schubert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ciurea 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.
citation: Cocker 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.
citation: Fountas 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.
citation: Rowland 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.
citation: Toi 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.
citation: Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.