Enhancing Recovery in Non-Traumatic Spinal Cord Injury

NCT03320759 | Recruiting

• 1 other identifier: 108706
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Compression; Spinal Cord Injuries; Cervical Spondylosis; Myelopathy Cervical

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• RAND Short form (SF)-36 Health Survey Questionnaire

  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

  Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)

• Myelopathy Disability Index (MDI)

  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

  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

  Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)

Study Arms (2)

No rehabilitation

NO INTERVENTION

Rehabilitation

EXPERIMENTAL

Behavioral: Occupational therapy rehabilitation

Interventions

Occupational therapy rehabilitation BEHAVIORAL

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.

Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• right-handed
• have a history of progressive neurological deficits \<24 months
• eligible for MRI scanning

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

LHSC - University Hospital

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Compression; Spinal Cord Injuries; Spondylosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Sarah Detombe, PhD

CONTACT

5196858500; sarah.detombe@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 25, 2017
• Study Start: August 21, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CA (1)