Status:

UNKNOWN

Personalized Neurorehabilitative Precision Medicine - From Data to Therapies

Lead Sponsor:

University Hospital Tuebingen

Collaborating Sponsors:

Interfaculty Institute for Biomedical Informatics (IBMI)

Cluster of Excellence - Machine Learning for Science

Conditions:

Stroke, Acute

Outcome, Improvement

Eligibility:

All Genders

18+ years

Brief Summary

Stroke is the most common neurological disease leaving one third dead and one third with permanent impairment despite best medical treatment. The aim of the present study is to investigate why patient...

Detailed Description

Clinical tests: Each subject will be assessed using the following tests: National Institute of Health Stroke Scale (NIHSS): The NIHSS is part of the usual highly standardized stroke workup. It consis...

Eligibility Criteria

Inclusion

  • Subject is 18 years or above.
  • Subject has an acute stroke affecting one UE (FMA less than 50).
  • Subject or understands the study and its procedures and gives informed consent.
  • If the subject is not able to give informed consent:
  • The assumed will of the patient is to be determined by the patient's provision (if existing), the health care proxy (if existing) and/or the moral concepts expressed by the patient to close relatives.
  • The legal representative gives informed consent because participation is the assumed will of the patient as assessed by the aforementioned points.

Exclusion

  • Subject is less than 18 years old.
  • The subject does not have an acute stroke, or stroke does not affect the UE, or FMA \> 50.
  • Subject or legal representative cannot give informed consent.
  • Patient has an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
  • Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
  • There is any concern by the investigator regarding the safe participation of the subject in the study, or for any other reason the investigator considers the subject inappropriate for participation in the study.
  • Subject is pregnant.

Key Trial Info

Start Date :

December 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2022

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04688970

Start Date

December 1 2020

End Date

June 30 2022

Last Update

December 30 2020

Active Locations (1)

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1

University hospital of Tuebingen

Tübingen, Baden-Wurttemberg, Germany, 72076