Clinical trial NCT03320759: 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
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Compression
Spinal Cord Injuries
Cervical Spondylosis
Myelopathy Cervical
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in levels of N-acetylaspartate (NAA) in the motor cortex
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: Changes to volume of activation in motor and supplementary motor cortices
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: Changes in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scores
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: Changes to intensity of cortical activation in motor and supplementary motor cortices
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Secondary outcomes:
measure: RAND Short form (SF)-36 Health Survey Questionnaire
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)]
measure: Modified Japanese Orthopaedic Association (mJOA) scale
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: Myelopathy Disability Index (MDI)
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
measure: Strength as tested with hand dynamometer
timeFrame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
Study officials:
References: