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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516385
Recruitment Status : Unknown
Verified January 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 24, 2012
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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 or disease
Spinal Cord Injury

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

spinal cord injury
other neurological conditions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516385

Contact: orna rahmim-katz, MD 972-3-5303715

Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52620
Contact: orna rahamim-katz, MD    972-3-5305715   
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Sheba Medical Center Identifier: NCT01516385     History of Changes
Other Study ID Numbers: SHEBA-12-8822-ORK-CTIL
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

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

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