Clinical trial NCT02537899: Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD
Official title: A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Lead sponsor: Moleac Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 to 65 years
* Diagnosed with spinal cord injury between 3 days and 4 weeks
* American Spinal Injury Association Impairment Scale A or B
* Informed consent for inclusion into the database is obtained

Exclusion Criteria:

* Non survivable injury
* Multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury
* Other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc)
* Refusal of treatment or contraindication to NeuroAiD

Primary outcomes:
measure: Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
timeFrame: 6 months
measure: Motor recovery based on American Spinal Injury Association Impairment Scale motor score
timeFrame: 6 months
measure: Number of patients experiencing adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
timeFrame: 1, 3, 12, 18, 24 months
measure: Motor recovery based on American Spinal Injury Association Impairment Scale motor score
timeFrame: 1, 3, 12, 18, 24 months
measure: Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Functional state based on Spinal Cord Independence Measure
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Quality of life based on Short Form-8 Health Survey
timeFrame: 1, 3, 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Kebangsaan Malaysia Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
citation: 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.
citation: 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.