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Behavioural Intervention

Spinal Cord Stimulation for Spasticity

N/A
Recruiting
Led By James Guest, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 22-70 years
GRASSP-Prehension score ≥10
Must not have
History of transverse myelitis
Requires ventilator support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate how practicing tasks while receiving spinal cord stimulation affects spasticity. The study will focus on how higher stimulation frequencies can impact spasticity in individuals with chronic spinal cord injury.

Who is the study for?
This trial is for adults aged 22-70 with non-progressive cervical spinal cord injury, at least a year post-injury. Participants must have some hand function (GRASSP score ≥10) and moderate to severe spasticity but not the most extreme form (MAS Score between 3 and <6). They should be able to lower Baclofen dosage to ≤30 mg daily, commit time-wise, and provide consent. Exclusions include other neurological diseases or conditions that could interfere with the study.
What is being tested?
The study tests how task practice combined with transcutaneous cervical spinal cord stimulation affects motor function and spasticity in individuals with chronic spinal cord injury. It specifically looks at whether higher frequencies of stimulation can reduce muscle stiffness/hypertonicity.
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort from the stimulation device, skin irritation where electrodes contact the skin, or an increase in muscle spasms due to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 70 years old.
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My hand function score is 10 or higher.
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My spinal cord injury in the neck area is not getting worse.
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I have partial paralysis but some sensory or motor function below the injury level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had transverse myelitis.
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I need a machine to help me breathe.
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I do not have uncontrolled heart or lung conditions.
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I have severe and uncontrolled sudden high blood pressure due to my spinal cord injury.
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My spinal cord injury is due to an autoimmune disease.
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I have a history of neurological conditions like stroke or epilepsy.
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I have nerve damage in my hands or feet.
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I do not have any unhealed bone fractures, muscle pain, contractures, pressure sores, or UTIs.
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I have not had Botulinum toxin injections in my upper body in the last 6 months.
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I do not have broken skin where electrodes will be placed.
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I am currently being treated for cancer or have been in remission for less than 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test
Secondary study objectives
Change in Spasticity as measured by Modified Ashworth Scale (MAS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Task Practice with stimulationExperimental Treatment1 Intervention
Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 4 months.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
948 Previous Clinical Trials
427,838 Total Patients Enrolled
ONWARD Medical, Inc.Industry Sponsor
4 Previous Clinical Trials
108 Total Patients Enrolled
James Guest, MD, PhDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
53 Total Patients Enrolled
~4 spots leftby Oct 2027
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