Personalized Neurorehabilitative Precision Medicine - From Data to Therapies

NCT04688970 | Unknown

• 1 other identifier: BNP-2020-09
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 patients differ in how they benefit from neurorehabilitation by collecting clinical, electrophysiological, imaging and laboratory data in the acute phase of stroke as well as later on during rehabilitation and after 90 days. Following a closed-loop approach the data is analyzed by a machine learning algorithm to create a personalized neurorehabilitation strategy.

Conditions

Stroke, Acute; Outcome, Improvement; Rehabilitation; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (1)

• Motor outcome of the upper extremity (UE) after acute stroke

  Fugl-Meyer Assessment for the upper extremity (FMA-UE) in the acute phase compared to the result after 90 days.

  90 days

Secondary Outcomes (4)

• Functional outcome of the UE after acute stroke

  90 days

• Independency in daily life after acute stroke

  90 days

• Independency in daily life after acute stroke

  90 days

• Qualitiy of life after acute stroke

  90 days

Study Arms (1)

Acute stroke with affection of the upper extremity

* Subject is 18 years or above. * Subject has an acute stroke affecting one UE (FMA less than 50). * Subject or caregiver 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.

Other: no intervention

Interventions

no intervention OTHER

no intervention

Acute stroke with affection of the upper extremity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include all patients with acute stroke affecting the UE (FMA less than 50) on our SU. Other symptoms like aphasia or neglect are no reason for exclusion since we intend to include as many patients as possible to capture the whole spectrum of stroke from mild to severe. Especially the last case, the inclusion of severely affected patients, is of utmost importance in our view. Due to their grave impairments they have the greatest need for neurorehabilitation; at the same time, this group of patients is the most vulnerable because of their preexisting comorbidities and conditions coming with immobility e. g. pneumonia. A personalized treatment would meet their need for intense rehabilitation while providing enough recreation time since unnecessary, ineffective rehabilitation could be omitted.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Interfaculty Institute for Biomedical Informatics (IBMI): collaborator
• Cluster of Excellence - Machine Learning for Science: collaborator
• Department for diagnostic and interventional neuroradiology, University hospital of Tuebingen: collaborator
• Deparmet of biomedical magnetic resonance, University hospital of Tuebingen: collaborator
• Kliniken Schmieder: collaborator
• SRH-Kliniken: collaborator

Study Sites (1)

University hospital of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

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MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Ziemann, PhD, M. d., Prof.

  Head of the department of neurology of the university hospital Tuebingen and Hertie-Institut for clinical brain research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinna Blum, PhD, M.d.

CONTACT

+4970712961788; neuroreha@med.uni-tuebingen.de

Christine Rösinger-Hein, PhD

CONTACT

+4970712961788; neuroreha@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 30, 2020
• Study Start: December 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

DE (1)