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SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.
SATURN is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as American Spinal Injury Association Impairment Scale A and B, who are treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | NeuroAiD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroAiD | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale | 6 months | |
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score | 6 months | |
| Number of patients experiencing adverse events | Adverse events as individual events and according to organ system, severity, and relatedness | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale | 1, 3, 12, 18, 24 months | |
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score | 1, 3, 12, 18, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Kebangsaan Malaysia Medical Centre | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35604343 | Derived | Kumar R, Htwe O, Baharudin A, Rhani SA, Ibrahim K, Nanra JS, Gsangaya M, Harun H, Kandar K, Balan M, Peh S, Pokharkar Y, Ingole A, Hisam Ariffin M. Spinal cord injury - assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study - primary results of an exploratory study. J Spinal Cord Med. 2023 Jul;46(4):682-686. doi: 10.1080/10790268.2022.2067972. Epub 2022 May 23. | |
| 27919862 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C546417 | Neuroaid |
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| Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score | 1, 3, 6, 12, 18, 24 months |
| Functional state based on Spinal Cord Independence Measure | 1, 3, 6, 12, 18, 24 months |
| Quality of life based on Short Form-8 Health Survey | 1, 3, 6, 12, 18, 24 months |
| Derived |
| Kumar R, Htwe O, Baharudin A, Ariffin MH, Abdul Rhani S, Ibrahim K, Rustam A, Gan R. Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN Study): Protocol of An Exploratory Study In Assessing the Safety and Efficacy of NeuroAiD Amongst People Who Sustain Severe Spinal Cord Injury. JMIR Res Protoc. 2016 Dec 5;5(4):e230. doi: 10.2196/resprot.6275. |
| D014947 | Wounds and Injuries |