Enhancing Recovery in Non-Traumatic Spinal Cord Injury

Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Cervical Spondylosis; Myelopathy Cervical; Spinal Cord Compression
• Intervention / Treatment: Behavioral: Occupational therapy rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Detombe, PhD; Phone Number: 35456 5196858500; Email: sarah.detombe@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • LHSC - University Hospital
      • Contact: Sarah Detombe; Phone Number: 35456 5196858500; Email: sarah.detombe@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No rehabilitation
Experimental: Rehabilitation	Behavioral: 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.

What is the study measuring?

Primary 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)

Secondary Outcome Measures

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)

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Diseases; Bone Diseases; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spondylosis; Spinal Cord Compression
• Other Study ID Numbers: 108706

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No