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.

NCT ID: NCT01516385

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Keywords

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spinal cord injury biomarkers rehabilitation functional independence prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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spinal cord injury

No interventions assigned to this group

other neurological conditions

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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orna rahmim-katz, MD

Role: CONTACT

Phone: 972-3-5303715

Email: [email protected]

Facility Contacts

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orna rahamim-katz, MD

Role: primary

Other Identifiers

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SHEBA-12-8822-ORK-CTIL

Identifier Type: -

Identifier Source: org_study_id