Detection of Peripheral Blood Biomarkers in Intermediate Phase Spinal Cord Injury: Correlation With Neurological and Functional Outcomes, and Comparison to Other Central and Peripheral Neurological Conditions.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01516385
First received: January 19, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

This research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. Investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and Guillain-Barre syndrome.

Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba medical center, Israel. They will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months.

Patients will be examined by the research staff three times:

  1. At arrival, the patients will be neurologically examined and their functional abilities will be assessed. Blood will be drawn and sent to the lab.
  2. At 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab.
  3. The final examination will take place 1 year after the beginning of the neurological condition. This time only the neurological and functional abilities will be assessed without blood tests.

The blood samples will be tested in the research lab. Then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 150
Study Start Date: January 2012
Groups/Cohorts
spinal cord injury
other neurological conditions

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients attmited for neuro-rehabilitation with spinal cord injury, stroke or Guillain-Barre syndrome

Criteria

Inclusion Criteria:

  • Diagnosis of traumatic or non-traumatic Spinal cord injury, Guillain-barre syndrome or Stroke
  • No more than 3 months after injury or disease onset
  • Condition severe enough to necessitate hospital/day care unit
  • Signed the informed consent form

Exclusion Criteria:

  • Psychiatric or cognitive situations that may interfere with the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516385

Contacts
Contact: orna rahmim-katz, MD 972-3-5303715 ornatova@gmail.com

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52620
Contact: orna rahamim-katz, MD    972-3-5305715    ornatova@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01516385     History of Changes
Other Study ID Numbers: SHEBA-12-8822-ORK-CTIL
Study First Received: January 19, 2012
Last Updated: January 26, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
spinal cord injury
biomarkers
rehabilitation
functional independence
prognosis

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 22, 2014