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

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ClinicalTrials.gov Identifier: NCT02999659
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment
Pupillary Function, Abnormal Cerebral Aneurysm 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
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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.




Primary Outcome Measures :
  1. 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.

  2. Number of perfusion deficiency [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Transcranial Doppler (TCD) -fluency increase [cm/s] [ Time Frame: 21 days ]
    > 150 cm/s absolute or increase > 50 cm/s within 24 h

  2. Digital subtraction angiography (DSA) [ Time Frame: day 7 ± 2 d ]
    Detection of an angiographic vasospasm

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999659


Contacts
Contact: Christina Kalvelage, M. Sc. 0241 80 85062 ckalvelage@ukaachen.de
Contact: Gerrit Alexander Schubert, PD Dr. med. 0241 80 88480 gschubert@ukaachen.de

Locations
Germany
Uniklinik RWTH Aachen Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Gerrit Alexander Schubert, PD Dr. med. Uniklinik RWTH Aachen

Publications:
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02999659     History of Changes
Other Study ID Numbers: 16-035
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by RWTH Aachen University:
pupillometry
autonomous nerve system

Additional relevant MeSH terms:
Pupil Disorders
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eye Diseases
Aneurysm
Intracranial Aneurysm
Neurologic Manifestations
Signs and Symptoms