Enhancing Recovery in Non-Traumatic Spinal Cord Injury
Primary Purpose
Spinal Cord Compression, Spinal Cord Injuries, Cervical Spondylosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Occupational therapy rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Compression
Eligibility Criteria
Inclusion Criteria:
- right-handed
- have a history of progressive neurological deficits <24 months
- eligible for MRI scanning
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No rehabilitation
Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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).
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.
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.
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.
Strength as tested with hand dynamometer
A device used to measure grip strength.
Full Information
NCT ID
NCT03320759
First Posted
September 27, 2017
Last Updated
June 20, 2018
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03320759
Brief Title
Enhancing Recovery in Non-Traumatic Spinal Cord Injury
Official Title
Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 patients recovering from spinal cord compression and is correlated with recovery and improved neurological scores.
The goal of this study is to combine a rigorous platform of clinical care that includes preoperative evaluation, surgery, and rehabilitation, with state of the art imaging techniques to demonstrate how rehabilitative therapy can increase brain plasticity and recovery of neurological function in patients with spinal cord injury. Neurological function will be carefully evaluated in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and will be correlated with the results of advanced imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Compression, Spinal Cord Injuries, Cervical Spondylosis, Myelopathy Cervical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No rehabilitation
Arm Type
No Intervention
Arm Title
Rehabilitation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Occupational therapy rehabilitation
Intervention Description
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 Measure Information:
Title
Changes in levels of N-acetylaspartate (NAA) in the motor cortex
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
Changes to volume of activation in motor and supplementary motor cortices
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
Changes in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scores
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
Changes to intensity of cortical activation in motor and supplementary motor cortices
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Secondary Outcome Measure Information:
Title
RAND Short form (SF)-36 Health Survey Questionnaire
Description
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).
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)]
Title
Modified Japanese Orthopaedic Association (mJOA) scale
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
Myelopathy Disability Index (MDI)
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
American Spinal Injury Association (ASIA) Impairment Scale
Description
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.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Title
Strength as tested with hand dynamometer
Description
A device used to measure grip strength.
Time Frame
Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
right-handed
have a history of progressive neurological deficits <24 months
eligible for MRI scanning
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Enhancing Recovery in Non-Traumatic Spinal Cord Injury
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