Recruiting

Observational Study

Sponsor:

Western University, Canada

Code:

NCT03320759

Conditions

Spinal Cord Compression

Spinal Cord Injuries

Cervical Spondylosis

Myelopathy Cervical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Occupational therapy rehabilitation

Study Details

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

Study ID

NCT03320759

Start date

Aug 21, 2018

Status verified date

Mar, 2024

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No rehabilitation

experimental: Rehabilitation

Interventions

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 measure

  • Changes in levels of N-acetylaspartate (NAA) in the motor cortex [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]

Central Contacts and Locations

Central contacts

Sarah Detombe, PhD

5196858500sarah.detombe@lhsc.on.ca

Locations

LHSC - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Sarah Detombe

5196858500sarah.detombe@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-03-28.