American Spinal Injury Association (ASIA) motor, functional and health related quality of life outcome in traumatic Central Cord Syndrome, a prospective randomized Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85867641

Enrollment

Registered

2007-06-06

Start date

2007-04-15

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Central Cord Syndrome Injury, Occupational Diseases, Poisoning Central Cord Syndrome

Interventions

30 patients (15 patients in each group) will undergo standard surgical decompression of spinal cord either within the first 5 days or at 6 weeks following spinal cord injury. Each of the 15 patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All adult patients (>17 years old) admitted to University of Maryland Medical System with traumatic central cord syndrome, canal compromise and evidence of spinal cord compression 2. Allen-Ferguson injury classification: 2.1. Distractive Extension Stage 1 2.2. Compressive Extension Stage 1 2.3. Vertical Compression Stage 1 2.4. Compressive Flexion Stage 1 3. Patient with American Spinal Injury Association (ASIA) level of injury from C4 to T1 inclusive 4. Patients with ASIA Impairment Grades B, C, and D/E 5. Pregnant and lactating women are also eligible for the study

Exclusion criteria

Exclusion criteria: 1. Children aged <18 2. Terminally ill patients, patients with non-survivable injuries and patients with demyelinating disease 3. Patients likely not to be able to appear for follow up 4. Allen-Ferguson Injuries: 4.1. Distractive Extension Stage 2, 3 4.2. Distractive Flexion Stages 1-4 4.3. Compressive Extension Stages 2-4 4.4. Vertical Compression Stages 2-4 4.5. Compressive Flexion Stages 2-4 4.6. Vertical Distraction Injuries 5. Patients with acute disc herniation in need of urgent decompression 6. Patients with progressive neurologic worsening 7. Patients with Spinal Cord Injury WithOut Radiological Abnormality (SCIWORA) 8. Central cord syndrome in association with traumatic brain injury (Glasgow Coma Scale [GCS]<15) 9. Patients with previous cervical spine injury and /or surgery. 10. ASIA (American Spinal Injury Association) grade A patients

Design outcomes

Primary

Measure	Time frame
ASIA Motor score after 3 months.	—

Secondary

Measure	Time frame
1. Functional outcomes will be assessed at 3 and 12 months after injury by the following: 1.1. Functional Independence Measure (FIM) 1.2. Spinal Cord Independence Measure (SCIM) 1.3. Walking Index of Spinal Cord Injury (WISCI) 1.4. Quality of life (Short Form-36) 2. Degree of canal compromise, spinal cord compression and syrinx size, assessed after admission and on pre-operation and post-operation CT and MRI studies of early or late decompression (i.e. after 5 days or after 6 weeks)	—

Measure

Time frame

1. Functional outcomes will be assessed at 3 and 12 months after injury by the following: 1.1. Functional Independence Measure (FIM) 1.2. Spinal Cord Independence Measure (SCIM) 1.3. Walking Index of Spinal Cord Injury (WISCI) 1.4. Quality of life (Short Form-36) 2. Degree of canal compromise, spinal cord compression and syrinx size, assessed after admission and on pre-operation and post-operation CT and MRI studies of early or late decompression (i.e. after 5 days or after 6 weeks)

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Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026