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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and four hours after each intervention session through study completion, an average of 2 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can understand and follow several instructions.
Select...
I have mild stiffness in my leg muscles.
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I am 16 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following each intervention session through study completion, an average of 2 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following each intervention session through study completion, an average of 2 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pendulum Test
Secondary outcome measures
Change in Ankle Clonus Test
Change in Plantar Flexor Reflex Response
Change in posterior root muscle reflexes (PRMRs)
+3 moreOther outcome measures
Modified SCI-SET
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
Find a Location
Who is running the clinical trial?
Shepherd Center, Atlanta GALead Sponsor
28 Previous Clinical Trials
3,630 Total Patients Enrolled
Edelle C Field-Fote, PT, PhDPrincipal InvestigatorShepherd Center, Atlanta GA
6 Previous Clinical Trials
294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal injury is below the T12 level.I have had a spinal cord injury for at least 3 months.I use long-term treatments for muscle spasms.You have any implanted device that gives off electrical signals, like a pacemaker or spinal stimulator.I do not have any active infections.I am 16 years old or older.I can understand and follow several instructions.I have a history of heart rhythm problems.I have cancer or have had cancer in the past.My spine condition is getting worse over time.You can tell someone if you are feeling pain or discomfort.I do not have severe joint stiffness that would stop me from joining.I have mild stiffness in my leg muscles.I am not pregnant and do not plan to become pregnant during the trial.I have skin issues that could worsen with treatment.My prescription medications have been stable for the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)
- Group 2: Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)
- Group 3: Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have joined the clinical trial to date?
"Affirmative, the information on clinicaltrials.gov confirms that this trial is actively seeking participants. The research project was first posted on January 20th 2020 and its details were most recently revised in September 15th 2022. This medical trial requires 46 volunteers from a single site."
Answered by AI
What are the hoped-for results of this clinical experiment?
"This trial's primary outcome is to measure the Change in Pendulum Test across a two-week span before and after intervention. Secondary outcomes include gauging changes in Plantar Flexor Withdrawal Test, Ankle Clonus Test, and posterior root muscle reflexes (PRMRs). To evaluate these indicators of efficacy, instrumented flexor reflex responses will be used alongside electrocutaneous stimulation delivered to patients' feet and electromyography electrodes placed on their lower extremity muscles. Additionally, an electrogoniometer will capture biomechanical data at the ankle joint while stimulating pulses via a Digitimer DS7A constant current"
Answered by AI
Is recruitment still open for this medical trial?
"Patient recruitment is presently ongoing for the clinical trial, with initial posting occuring on January 20th 2020 and most recent updates made on September 15th 2022."
Answered by AI
To what demographic is this trial most applicable?
"To qualify for this clinical trial, prospective participants must have suffered a spinal cord trauma and be between 16 and 65 years of age. Currently, the research team is looking to enrol 46 patients in total."
Answered by AI
Is this trial open to individuals aged sixty and above?
"Within this medical study, prospective participants must be of an age between 16 and 65."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Maryland
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Shepherd Center, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Constant pain and back spasms unable to care for myself.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Shepherd Center, Inc.: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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