Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
NCT ID: NCT02999659
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
300 participants
OBSERVATIONAL
2016-12-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx
NCT04490005
Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
NCT07282691
Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker
NCT07141719
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
NCT00131729
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
NCT03319966
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Pupilometer
Device to measure change in pupil diameter due to a defined light stimulus.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pupilometer
Device to measure change in pupil diameter due to a defined light stimulus.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RWTH Aachen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gerrit Alexander Schubert
apl. Prof. Dr. med. Gerrit Alexander Schubert
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerrit Alexander Schubert, Prof.
Role: PRINCIPAL_INVESTIGATOR
Uniklinik RWTH Aachen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
Ciurea AV, Palade C, Voinescu D, Nica DA. Subarachnoid hemorrhage and cerebral vasospasm - literature review. J Med Life. 2013 Jun 15;6(2):120-5. Epub 2013 Jun 25.
Cocker KD, Moseley MJ, Stirling HF, Fielder AR. Delayed visual maturation: pupillary responses implicate subcortical and cortical visual systems. Dev Med Child Neurol. 1998 Mar;40(3):160-2. doi: 10.1111/j.1469-8749.1998.tb15440.x.
Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.
Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264.
Toi H, Matsumoto N, Yokosuka K, Matsubara S, Hirano K, Uno M. Prediction of cerebral vasospasm using early stage transcranial Doppler. Neurol Med Chir (Tokyo). 2013;53(6):396-402. doi: 10.2176/nmc.53.396.
Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-035
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.