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NCT07501429 · ClinicalTrials.gov registry record · Phase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
A Phase 1 study, sponsored by Kessler Foundation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07501429 is a Phase 1 study that is actively recruiting participants, run by Kessler Foundation. The registered enrollment target is 12 participants.
The verdict
NCT07501429, a Phase 1 study, is actively recruiting participants, sponsored by Kessler Foundation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or stretching; medications such as Baclofen; and injections with agents like botulinum toxin (also known as Botox). Botox injections are often implemented alongside other modalities like therapy, yet they are invasive, tend to last for only a few months, and carry potential side effects. One potential non-invasive treatment for upper limb spasticity is focused extracorporeal shockwave therapy (f-ESWT), which involves an external application of high-pressure sound waves, similar to ultrasound. An applicator/handpiece is placed on the skin over the spastic muscle and the focused sound waves are applied. f-ESWT carries no long-term side effects with minimal discomfort during application. However, there has been limited research on this treatment option in people with SCI who have arm and hand dysfunction caused by spasticity. The purpose of this study is to fill in that knowledge gap. This will be accomplished by measuring different aspects of spasticity from the perspective of both the clinician and the person with SCI. These will include clinical measures, such as elbow and wrist range of
Interventions
- DEVICE Focused extracorporeal shockwave therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-04 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07501429
The ClinicalTrials.gov registry entry for NCT07501429 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Focused extracorporeal shockwave therapy is the first listed.
NCT07501429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07501429 about?
NCT07501429 is a clinical study titled "Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury". Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder...
What is the current status of trial NCT07501429?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-04. Estimated completion is 2028-12.
What interventions are being tested in trial NCT07501429?
The interventions under investigation include: Focused extracorporeal shockwave therapy (DEVICE).
Who is sponsoring clinical trial NCT07501429?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
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