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

Cerebral Aneurysm Clinical Trial

— Pupillometry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999659
• Other study ID #: 16-035
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: RWTH Aachen University
• Contact: Christina Kalvelage, M. Sc.
• Phone: 0241 80 85062
• Email: ckalvelage[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm
• Pupillary Function, Abnormal

Intervention

Device:
• Pupilometer
Device to measure change in pupil diameter due to a defined light stimulus.

Locations

Country	Name	City	State
Germany	Uniklinik RWTH Aachen	Aachen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of perfusion deficiency		21 days
Secondary	Transcranial Doppler (TCD) -fluency increase [cm/s]	> 150 cm/s absolute or increase > 50 cm/s within 24 h	21 days
Secondary	Digital subtraction angiography (DSA)	Detection of an angiographic vasospasm	day 7 ± 2 d
Secondary	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