Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome (Pupillometry)

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Aneurysm; Pupillary Function, Abnormal
• Intervention / Treatment: Device: Pupilometer

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Christina Kalvelage, M. Sc.; Phone Number: 0241 80 85062; Email: ckalvelage@ukaachen.de
• Study Contact Backup: Name: Gerrit Alexander Schubert, Prof.; Phone Number: 0241 80 88480; Email: gschubert@ukaachen.de

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Recruiting
      • Uniklinik RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Pupilometer; Device to measure change in pupil diameter due to a defined light stimulus.
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.	Device: Pupilometer; Device to measure change in pupil diameter due to a defined light stimulus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcranial Doppler (TCD) -fluency increase [cm/s]	> 150 cm/s absolute or increase > 50 cm/s within 24 h	21 days
Digital subtraction angiography (DSA)	Detection of an angiographic vasospasm	day 7 ± 2 d
Glasgow Outcome Score (GOS)	Standardized and objective description of the degree of recovery of patients suffered from a cerebral disease.	after 3 and 6 month

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Gerrit Alexander Schubert, Prof., Uniklinik RWTH Aachen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pupillometry; autonomous nerve system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Pupil Disorders
• Other Study ID Numbers: 16-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED