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

NCT07501429 | Recruiting Phase 1 FDA Device

• 1 other identifier: R-1311-26
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Cord Injury; Spasticity; Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Modified Ashworth Scale scores

  The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion. Scores range from 0 (no spasticity) to 4 (severe spasticity).

  4 weeks

Secondary Outcomes (11)

• Change in Modified Ashworth Scale scores

  8 weeks

• Change in Modified Penn Spasticity Frequency Scale

  4 weeks

• Change in Modified Penn Spasticity Frequency Scale

  8 weeks

• Change in Modified Patient-Reported Impact of Spasticity Measure

  4 weeks

• Change in Modified Patient-Reported Impact of Spasticity Measure

  8 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Elbow and Wrist Flexor Focused Extracorporeal Shockwave Therapy

Device: Focused extracorporeal shockwave therapy

Interventions

Focused extracorporeal shockwave therapy DEVICE

Three sessions of focused extracorporeal shockwave therapy, applied to forearm and elbow flexor muscles.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Have chronic, non-progressive SCI of all levels and severities that occurred greater than 1 year prior to their enrollment.
• MAS score of between 1+ and 3 in elbow and wrist flexors of the treated upper limb.
• 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
• No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
• Participant is able and willing to comply with the protocol.

You may not qualify if:

• History of surgical procedures in the upper extremity
• Severe, inflammatory arthritic diseases
• Thrombosis
• Anticoagulant medication;
• Pregnancy
• Cancer
• Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol within the 12 months

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shalaka Paranjpe, MS

CONTACT

973-327-3572; sparanjpe@kesslerfoundation.org

Nathan Hogaboom, PhD

CONTACT

973-324-3584; nhogaboom@kesserfoundation.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)