Regeneration in Cervical Degenerative Myelopathy

Surgery
Arm/hand function
Online since 21 February 2024, updated 6 days ago

About this trial

This trial will test whether the drug ibudilast improves recovery in individuals undergoing spinal decompression surgery for Degenerative Cervical Myelopathy (DCM). DCM is a degenerative arthritic condition causing loss of nerve function due to pressure on the spinal cord. Previous studies indicate that ibudilast is safe and may protect spinal cord nerves and promote their recovery. If included in the trial, participants with DCM who are planning to have decompression surgery will be randomly assigned to take either oral ibudilast or a placebo drug beginning up to 10 weeks prior to surgery and continuing for up to 24 weeks after surgery. Researchers will measure changes in motor and sensory function in the upper and lower extremities, bladder emptying function, and neck pain. Questionnaires on health and well-being will also be given. These assessments will be performed periodically before and up to 12 months after surgery. Pre-operative and 6-month post-operative MRI scans of the neck will also be performed.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 80 years
  • Injury type
  • Non-traumatic

    Stenosis

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    have a cervical degenerative myelopathy (spinal cord compression with neurological impairment because of degenerative disease of the cervical spine)
    have a preoperative modified Japanese Orthopedic Association (mJOA) score ≥8 and ≤14 (consistent with moderate to severe neurological impairment)
    not have had previous surgical decompression of the cervical spine

    What’s involved

    Type

    Surgery

    Details

    Undergo a planned spinal decompression surgery to relieve pressure on the cervical spinal cord. Daily oral dosing of study medication (Ibudilast or placebo) starting up to 10 weeks prior to surgery, and continuing for up to 24 weeks after surgery (total of up to 34 weeks) Participate in study outcome assessments periodically beginning at baseline before surgery to 12 months after surgery.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    Bladder health

    Bone health

    General health

    Mental health

    Pain

    Sensory function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Dec 2021
    • Organisation
    • Cambridge University Hospitals NHS Foundation Trust
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Dec 2021
    • Organisation
    • Cambridge University Hospitals NHS Foundation Trust

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more