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Clinical Trial NCT03320759 for Spinal Cord Compression, Spinal Cord Injuries, Cervical Spondylosis, Myelopathy Cervical is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Enhancing Recovery in Non-Traumatic Spinal Cord Injury 40
Clinical Trial NCT03320759 is an interventional study for Spinal Cord Compression, Spinal Cord Injuries, Cervical Spondylosis, Myelopathy Cervical that is recruiting. It started on 21 August 2018 with plans to enroll 40 participants. Led by Western University, Canada, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 28 March 2024.
Brief Summary
The investigators have spent the last decade uncovering unique metabolic and functional abnormalities in the brains of patients with spinal cord compression. Degenerative spinal cord compression represents a unique model of reversible spinal cord injury. In the investigator's previous work, they have demonstrated that cortical reorganization and recruitment is associated with metabolic changes in the brains of patien...Show More
Official Title
Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies
Conditions
Spinal Cord CompressionSpinal Cord InjuriesCervical SpondylosisMyelopathy CervicalOther Study IDs
- 108706
NCT ID Number
Start Date (Actual)
2018-08-21
Last Update Posted
2024-03-28
Completion Date (Estimated)
2026-07-01
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionNo rehabilitation | N/A |
ExperimentalRehabilitation | Occupational therapy rehabilitation Participants in the experimental arm will receive occupational therapy that is individualized to each participant's needs from week 4 post-decompression surgery until week 12. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in levels of N-acetylaspartate (NAA) in the motor cortex | It is expected that the group of patients receiving rehabilitation will experience less decline in NAA concentrations as compared to the second group of patients not receiving rehabilitation. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Changes to volume of activation in motor and supplementary motor cortices | Volume of activation is measured by calculating the voxel number within our selected cortical regions, the motor cortex and supplementary motor cortex, using functional magnetic resonance imaging (fMRI). Changes in these numbers demonstrate volume of cortical activation changes in these regions. Following rehabilitation, the investigators expect that the volume of cortical activation of patients, expressed as voxel number, will change between time points compared with changes observed in the control group. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Changes in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scores | Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) is an indicator of dorsal and palmar sensation, strength (by myotome) and prehension (grasping). GRASSP is a standardized measure to assess hand function in ways that are meaningful in the context of a patient's overall ability to complete activities of daily living. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Changes to intensity of cortical activation in motor and supplementary motor cortices | Intensity of cortical activation is expressed as signal intensity in beta weights. Following rehabilitation, the investigators expect that the intensity of cortical activation in participants in the intervention group will change between time-points compared with changes observed in the control group. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
RAND Short form (SF)-36 Health Survey Questionnaire | General health status self-administered evaluation tool. Better scores in the intervention group are expected. Composite score will be reported. The range for this score is from 0 to 100, with 100 indicating the best general health status possible. Subscale scores also range from 0-100 and are simply an average of the scores for each of their relevant questions. Subscales are combined into a composite score by averaging results of all subscales, which is the methodology specified by the creators of the scale (RAND). | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)] |
Modified Japanese Orthopaedic Association (mJOA) scale | A clinical tool used to evaluate impairment due to cervical spondylotic myelopathy, including loss of sensation, motor abilities in limbs, and bowel and bladder control. The lowest possible score is a 0 and the highest, 18. Higher numbers indicate better functioning. Item scores are simply summed to arrive at the composite score. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Myelopathy Disability Index (MDI) | This self-administered questionnaire is used to measure the degree to which myelopathy has affected the participant's ability to perform activities of daily living. Raw scores will be calculated for each participant and may range from 0 to 30. To arrive at the participant's raw score, item scores are simply summed. The final scores used for analysis will be the participant's score expressed as a percentage. Higher scores indicate greater impairment. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
American Spinal Injury Association (ASIA) Impairment Scale | A clinical assessment tool used to classify motor and sensory impairment in persons with myelopathy. Subscales to be reported include the right and left motor scores (range=0-50 for both) and the right and left sensory scores (range=0-60 for both). Higher scores indicate less impairment. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Strength as tested with hand dynamometer | A device used to measure grip strength. | Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- right-handed
- have a history of progressive neurological deficits <24 months
- eligible for MRI scanning
- having any other neurological disorder or systemic disease that can impair neurological function
- not fluent in reading and speaking English
- being claustrophobic
- unable to follow simple task instructions and maintain standardized movements
- being unable to return for all follow-up imaging and rehabilitation sessions
Study Central Contact
Contact: Sarah Detombe, PhD, 5196858500, [email protected]
1 Study Locations in 1 Countries
Ontario
LHSC - University Hospital, London, Ontario, N6A 5A5, Canada
Sarah Detombe, Contact, 5196858500, [email protected]
Recruiting