Using exoskeletons to reduce neuropathic pain after spinal cord injury
Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial
This study is testing if using a robotic exoskeleton for walking can help reduce nerve pain in people who have had a spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin) |
| Trial ID | NCT06463418 on ClinicalTrials.gov |
What this trial studies
This feasibility trial aims to determine if robotic walking using an exoskeleton can help reduce neuropathic pain in individuals with traumatic spinal cord injuries. Participants will engage in robotic walking sessions three times a week for twelve weeks, while a control group will follow a relaxation program. The study will assess the feasibility of the intervention, participant adherence, and its effectiveness in alleviating pain through questionnaires and tests conducted before, after, and six months post-intervention. Additionally, participants will share their experiences through interviews.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with confirmed traumatic spinal cord injuries and persistent neuropathic pain despite pharmacotherapy.
Not a fit: Patients who do not have neuropathic pain or those with spinal cord injuries resulting from non-traumatic causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce neuropathic pain and improve the quality of life for individuals with spinal cord injuries.
How similar studies have performed: While the use of robotic devices for rehabilitation is gaining traction, this specific approach to addressing neuropathic pain through exoskeleton training is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who are 18 years and over. * Confirmed traumatic SCI (injury resulted from an external physical impact and not an acute or chronic disease process) of \>6 months duration with complete or incomplete paraplegia or tetraplegia. * Individuals with above confirmed traumatic SCI who have below-level NP (≥ 3 levels below neurological level and/or extending to at-level region) starting after the SCI and persisting for \> 3 continuous months, despite pharmacotherapy. * NP will be confirmed based on a neurological examination, a score of ≥4 on the Douleur Neuropathique 4 (DN4) (48) and a comprehensive pain history supported by the use of the ISCIP Pain Classification. They endorse one or more of the following pain descriptors to assist in confirmation of below level NP "'hot-burning', 'tingling', 'pricking', 'pins and needles', 'sharp', 'shooting', 'squeezing', 'painful cold' and 'electric shock-like'" (45). * Moderate and severe NP as confirmed above will be described as pain ≥ 3 and ≥ 6 on the 0-10 Numerical Rating Scale (NRS) for NP (averaged over a week). * Exoskeleton naive * Stable medication regimen * Have the capacity to provide informed consent. Exclusion Criteria: * Non-traumatic SCI, cauda equina lesions or Guillain Barré diagnoses * NP intensities of \<3 (NRS) or nociceptive pain profiles only based on the ISCIP pain classification convention. * Recent lower limb fracture * Inadequate bone density (z score \< -2) * Anthropometric measurements incompatible with the exoskeleton device (i.e. height \>1.9m, weight \>100kgs, significant lower limb spasticity) * Unstable comorbid medical condition/psychiatric condition/medication regimen * Planned surgery coinciding with intervention * Pregnancy * Drug and alcohol abuse
Where this trial is running
Dublin
- University College Dublin — Dublin, Ireland (Recruiting)
Study contacts
- Principal investigator: Olive Lennon, PhD — University College Dublin
- Study coordinator: Olive Lennon, PhD
- Email: olive.lennon@ucd.ie
- Phone: +3537166508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.