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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: RWTH Aachen University

Current Primary Outcome:

  • Number of delayed cerebral ischemia (DCI) [ Time Frame: 21 days ]
    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.
  • Number of perfusion deficiency [ Time Frame: 21 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: RWTH Aachen University

Dates:
Date Received: December 19, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: December 19, 2016
Last Verified: December 2016