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

Study Overview
=================
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.

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

Conditions
-----------------
Pupillary Function, Abnormal, Cerebral Aneurysm

Intervention / Treatment
-----------------
* Device: Pupilometer


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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<br>* Device to measure change in pupil diameter due to a defined light stimulus.<br>|
| Treatment group<br>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<br>* Device to measure change in pupil diameter due to a defined light stimulus.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pupillometry, autonomous nerve system