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

RWTH Aachen University

Status: Unknown

Conditions: Pupillary Function, Abnormal; Cerebral Aneurysm

Treatments: Device: Pupilometer

Study type: Observational

Funder types: Other

Identifiers

NCT02999659

16-035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Control group

Description:

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.

Treatment:

Device: Pupilometer

Treatment group

Description:

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.

Treatment:

Device: Pupilometer