Spinal Cord InjuryPhase 1NCT07501429
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
A Phase 1 study testing Focused extracorporeal shockwave therapy in people with Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Spasticity, Shockwave Therapy
- What is being tested?
- Focused extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Shalaka Paranjpe, 973-327-3572, sparanjpe@kesslerfoundation.org
Nathan Hogaboom, PhD
About this study
Official title: Pilot Trial of a Novel, Non-invasive Treatment for Upper-limb 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 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
- Being tested
- Focused extracorporeal shockwave therapy
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused extracorporeal shockwave therapyDevice
Three sessions of focused extracorporeal shockwave therapy, applied to forearm and elbow flexor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Elbow and Wrist Flexor Focused Extracorporeal Shockwave Therapy Receives: Device: Focused extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (11)
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).
Measured: 8 weeks
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Measured: 4 weeks
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Measured: 8 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable.
Measured: 4 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable.
Measured: 8 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 ["very much worse"] and 7 ["very much improved"]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome.
Measured: 4 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 ["very much worse"] and ["very much improved"]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome.
Measured: 8 weeks
Biceps brachii muscle echogenicity
Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of biceps muscle in longitudinal view.
Measured: 4 weeks
Biceps brachii muscle echogenicity
Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of biceps muscle in longitudinal view.
Measured: 8 weeks
Biceps brachii muscle elasticity
Elasticity is a measure of a tissue's stiffness. Muscles that are more spastic and have a greater concentration of connective tissue appear stiffer than those in better health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average elasticity of biceps muscle in longitudinal view.
Measured: 4 weeks
Biceps brachii muscle elasticity
Elasticity is a measure of a tissue's stiffness. Muscles that are more spastic and have a greater concentration of connective tissue appear stiffer than those in better health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average elasticity of biceps muscle in longitudinal view.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start6 Mar 2026
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Hogaboom, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501429
- Sponsor's protocol ID
- R-1311-26
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared to protect participants' private clinical data.