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

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Brief Title

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

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 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


Primary Outcome

Number of delayed cerebral ischemia (DCI)

Secondary Outcome

 Transcranial Doppler (TCD) -fluency increase [cm/s]

Condition

Pupillary Function, Abnormal

Intervention

Pupilometer

Study Arms / Comparison 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

300

Start Date

December 2016

Completion Date

December 2020

Primary Completion Date

December 2020

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gerrit Alexander Schubert, Prof., 0241 80 85062, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02999659

Organization ID

16-035


Responsible Party

Principal Investigator

Study Sponsor

RWTH Aachen University


Study Sponsor

Gerrit Alexander Schubert, Prof., Principal Investigator, Uniklinik RWTH Aachen


Verification Date

September 2019