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Electrical Stimulation
Spinal Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Edelle 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
Participants should be 16 years old or older
Must not have
People with broken skin
People with heart issues, such as atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how different types of noninvasive electrical stimulation affect muscle issues and pain in people with spinal cord injuries. The treatment involves placing electrodes on the skin to send electrical pulses to the spine. Researchers hope to find the best way to use these pulses to reduce muscle problems and pain.
Who is the study for?
This trial is for individuals aged 16 or older who have had a spinal cord injury at least 3 months prior, with some leg spasticity. Participants should be able to follow instructions and communicate discomfort. They must consent to health information usage and report any changes in prescription medications during the study.
What is being tested?
The study tests how different frequencies of noninvasive spinal stimulation affect muscle control, involuntary muscle activity (spasticity), and pain after a spinal cord injury. It involves electrical stimulation over the lower back and stomach, requiring visits to Shepherd Center for sessions across several weeks.
What are the potential side effects?
Potential side effects may include discomfort or pain at the stimulation site, skin irritation from electrodes, temporary increase in spasticity or muscle weakness post-treatment. The severity can vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have broken skin.
Select...
I have a heart condition like atrial fibrillation.
Select...
I have received long-term treatments for muscle stiffness.
Select...
My spinal cord injury is below the T12 level.
Select...
My spinal condition is worsening over time.
Select...
I have bone or joint issues that could interfere with study participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pendulum Test
Secondary study objectives
Ankle Clonus Test
Global Rating of Change Scale
Modified Penn Spasm Frequency Scale
+5 moreAwards & 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: 80 Hz FrequencyExperimental Treatment1 Intervention
Intervention will be applied with an 80 Hz frequency.
Group II: 50 Hz FrequencyExperimental Treatment1 Intervention
Intervention will be applied with a 50 Hz frequency.
Group III: 30 Hz FrequencyExperimental Treatment1 Intervention
Intervention will be applied with a 30 Hz frequency.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Noninvasive spinal stimulation, such as electrical stimulation applied through skin electrodes, works by delivering electrical impulses to the spinal cord and surrounding nerves. This stimulation can modulate neural activity, reduce spasticity (involuntary muscle activity), and improve motor control and pain management.
For spinal cord injury patients, these mechanisms are crucial as they can enhance muscle function, decrease pain, and improve overall quality of life. By targeting specific neural pathways, electrical stimulation helps in restoring some degree of motor function and reducing the debilitating effects of spasticity and chronic pain.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,829 Previous Clinical Trials
8,169,845 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,063 Previous Clinical Trials
2,746,293 Total Patients Enrolled
Shepherd Center, Atlanta GALead Sponsor
29 Previous Clinical Trials
3,965 Total Patients Enrolled