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Transcutaneous Spinal Stimulation for Spinal Cord Injury

N/A

Waitlist Available

Led By Edelle C Field-Fote, PT, PhD

Research Sponsored by Shepherd Center, Atlanta GA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to follow multiple commands

Have at least mild "spasticity" affecting lower extremity muscles, as indicated by a pendulum test first swing excursion angle of ≤ 77° or ≥ 5 beats of clonus on the ankle drop test

Must not have

Active cancer or a history of cancer

Orthopedic pathology that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following each intervention session through study completion, an average of 2 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of different intensities of transcutaneous spinal stimulation on spasticity in people with SCI.

Who is the study for?

This trial is for individuals aged 16 or older with any severity of spinal cord injury (SCI) that occurred at least 3 months ago and causes mild to severe spasticity. Participants must be stable on their current medications, able to communicate discomfort, and not have progressive spinal issues, cardiovascular irregularities, active cancer, certain orthopedic limitations, semi-permanent anti-spasmodic treatments like botox, pregnancy, implanted stimulators or active infections.

What is being tested?

The study investigates the effects of Transcutaneous Spinal Stimulation (TSS), a non-drug electrical stimulation therapy applied over the spine skin to reduce spasticity in SCI patients. It aims to determine the optimal intensity level for managing spasticity without medication side effects.

What are the potential side effects?

Potential side effects may include discomfort or pain at the stimulation site, skin irritation or lesions due to electrical stimulation. Since TSS is non-pharmacological there are no drug-related side effects; however individual responses can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and follow several instructions.

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I have mild stiffness in my leg muscles.

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I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer or have had cancer in the past.

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I do not have severe joint stiffness that would stop me from joining.

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I use long-term treatments for muscle spasms.

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My spinal injury is below the T12 level.

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I have a history of heart rhythm problems.

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My spine condition is getting worse over time.

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I am not pregnant and do not plan to become pregnant during the trial.

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I have skin issues that could worsen with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completed during the enrollment session only.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completed during the enrollment session only.

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed during the enrollment session only. 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 Pendulum Test

Secondary study objectives

Change in Ankle Clonus Test

Change in Plantar Flexor Reflex Response

Change in posterior root muscle reflexes (PRMRs)

+3 more

Other study objectives

Modified SCI-SET

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Group II: Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied continuously at two sites at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Group III: Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous spinal stimulation

2022

N/A

~40

0 / 11Eligibility criteria met