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Electrical Stimulation
30 Hz Frequency 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 minutes
Awards & highlights
Study Summary
This trial aims to see how different types of noninvasive spinal stimulation can affect muscle activity, strength, and pain in individuals with spinal cord injuries. Participants will receive electrical stimulation on their lower back and
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pendulum Test
Secondary outcome measures
Ankle Clonus Test
Global Rating of Change Scale
Modified Penn Spasm Frequency Scale
+5 moreTrial 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.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,804 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,751 Total Patients Enrolled
Shepherd Center, Atlanta GALead Sponsor
28 Previous Clinical Trials
3,605 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of subjects being examined in this particular research investigation?
"Indeed, data on clinicaltrials.gov indicates that this medical investigation is actively seeking participants. Initially shared on February 19th, 2024, and most recently revised on February 23rd, 2024, the trial aims to recruit a total of 46 patients from one designated site."
Answered by AI
Are potential candidates still eligible to participate in this ongoing clinical trial?
"As per the details on clinicaltrials.gov, this particular study is actively seeking participants. It was initially posted on February 19th, 2024, and recently amended on February 23rd, 2024."
Answered by AI
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