Focused shockwave treatment for elbow and wrist spasticity after spinal cord injury
Pilot Trial of a Novel, Non-invasive Treatment for Upper-limb Spasticity in People With Spinal Cord Injury
This project will try focused extracorporeal shockwave therapy on the elbow and wrist to reduce spasticity in adults with chronic spinal cord injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT07501429 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional protocol will deliver focused extracorporeal shockwave therapy to the elbow and wrist flexor muscles of adults with chronic, non-progressive spinal cord injury and measurable spasticity. Eligible participants must have had their injury for more than one year and Modified Ashworth Scale scores between 1+ and 3 in the treated muscles, with stable antispasmodic medications. Key exclusions include recent local botulinum toxin or phenol/alcohol injections, anticoagulant use, recent infection at the treatment site, pregnancy, cancer, or severe inflammatory joint disease. The primary focus is early safety and tolerability of the shockwave intervention in this population at a single site.
Who should consider this trial
Good fit: Adults (18+) with chronic (>1 year), non-progressive spinal cord injury who have moderate elbow and wrist flexor spasticity (MAS 1+ to 3), stable antispasmodic medications, and no contraindications to shockwave treatment are ideal candidates.
Not a fit: Patients with severe or very mild spasticity outside the MAS range, recent botulinum toxin/phenol injections, upper-extremity surgery, anticoagulant use, pregnancy, active cancer, thrombosis, or inflammatory arthritic disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy could reduce arm and hand spasticity and improve function, pain, and daily independence for people with tetraplegia.
How similar studies have performed: Extracorporeal shockwave has shown promise for spasticity in post-stroke and other populations, but its application to upper-limb spasticity after spinal cord injury is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or older. 2. Have chronic, non-progressive SCI of all levels and severities that occurred greater than 1 year prior to their enrollment. 3. MAS score of between 1+ and 3 in elbow and wrist flexors of the treated upper limb. 4. Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).129 5. No change in antispasmodic medications within the past three months or intended changes over the course of the trial. 6. Participant is able and willing to comply with the protocol. Exclusion Criteria: 1. History of surgical procedures in the upper extremity 2. Severe, inflammatory arthritic diseases 3. Thrombosis 4. Anticoagulant medication; 5. Pregnancy 6. Cancer 7. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol within the 12 months
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Shalaka Paranjpe, MS
- Email: sparanjpe@kesslerfoundation.org
- Phone: 973-327-3572
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.