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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.

This study is not yet open for participant recruitment.
Verified January 2012 by Sheba Medical Center
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
History of Changes

January 19, 2012
January 26, 2012
January 2012
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Complete list of historical versions of study NCT01516385 on ClinicalTrials.gov Archive Site
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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.
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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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All patients attmited for neuro-rehabilitation with spinal cord injury, stroke or Guillain-Barre syndrome
Spinal Cord Injury
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  • spinal cord injury
  • other neurological conditions
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
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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
Both
18 Years to 75 Years
No
Contact: orna rahmim-katz, MD 972-3-5303715 ornatova@gmail.com
Israel
 
NCT01516385
SHEBA-12-8822-ORK-CTIL
No
Sheba Medical Center
Sheba Medical Center
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Sheba Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP