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Recruiting Phase 1 Interventional

Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury

ClinicalTrials.gov ID: NCT07501429

Public ClinicalTrials.gov record NCT07501429. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pilot Trial of a Novel, Non-invasive Treatment for Upper-limb Spasticity in People With Spinal Cord Injury

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 motion, as well as how the treatment impacts the person's functional independence and quality of life. Ultrasound methods will be used to look at the person's muscles to see if any beneficial changes occur in their structure and stiffness. People with SCI who meet eligibility criteria will be invited to the laboratory to receive f-ESWT, which will occur once per week for three consecutive weeks. Treatment will entail application of f-ESWT to the elbow and wrist flexor muscles. Participants will be invited back to the laboratory to have their spasticity measured by a clinician, be asked questions about how their spasticity has impacted their lives, and have their muscles imaged with ultrasound. Findings from this study are expected to generate insight on whether f-ESWT could be a viable treatment option for spasticity of the arms and hands in people with SCI, and if a larger clinical trial is warranted.

Study identification

NCT ID
NCT07501429
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Kessler Foundation
Other
Enrollment
12 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2026
Primary completion
Aug 31, 2028
Completion
Nov 30, 2028
Last update posted
Mar 29, 2026

2026 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Kessler Foundation West Orange New Jersey 07052 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07501429, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07501429 live on ClinicalTrials.gov.

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