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Electrical Stimulation
Spinal Cord Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Emily Fox, DPT, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 8
Awards & highlights
Study Summary
This trial will explore if combining a non-invasive spinal stimulation with a locomotor training program can improve walking after spinal cord injury.
Who is the study for?
This trial is for adults aged 18-65 with a chronic spinal cord injury at T12 or above, who can walk 3 meters with assistance. They must be medically stable and able to consent. Excluded are those with skin wounds, severe spasticity, pregnancy, unstable conditions like heart disease, cognitive impairments, other neurological disorders, joint contractures that limit walking ability, visual impairment preventing safe participation in rehabilitation activities.Check my eligibility
What is being tested?
The AMPLIFY Study tests whether adding transcutaneous spinal direct current stimulation (tsDCS) to locomotor training helps improve walking after an incomplete spinal cord injury. Participants will receive either a high dose or low dose of tsDCS while undergoing walking rehabilitation exercises.See study design
What are the potential side effects?
Potential side effects from tsDCS may include mild discomfort or tingling at the stimulation site during treatment. There's also a small risk of skin irritation under the electrodes used for tsDCS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 10-Meter Walk Test (10MWT)
Change in 6-Minute Walk Test (6MWT)
Change in H-Reflex Gait Phase Modulation
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose InterventionExperimental Treatment1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. For the high dose group, a standard dosage of 30 continuous minutes of 2.5 mA stimulus will be used.
Group II: Low Dose InterventionActive Control1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. The low dose condition will use an identical montage and stimulation arrangement, except the stimulation will be delivered briefly at the beginning and end of the stimulation period (30 seconds) with a three-second ramp.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,660 Total Patients Enrolled
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,735 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,917 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in a program to improve my walking.My pain restricts my ability to walk or join in walking rehab.I am legally blind or have severe vision problems.I have a neurological condition like MS, Parkinson's, stroke, or brain injury.I can communicate clearly and understand the study's details.I cannot stand or walk properly due to joint stiffness in my legs.I do not have any uncontrolled health issues like heart disease or infections.I have severe muscle stiffness or uncontrollable movements that make it hard for me to participate in walking exercises.I am between 18 and 65 years old.I have skin issues that prevent me from walking exercises.I have not had Botox injections in my leg muscles within the last 4 months.I can walk 3 meters by myself or with help.I have had a spinal cord injury above T12 for over a year and have some motor function.I don't have recent fractures or severe joint/bone issues affecting my ability to walk.I have metal implants in my spine below the chest area or near where an electrode might be placed.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose Intervention
- Group 2: Low Dose Intervention
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.
Does this clinical trial accommodate geriatric patients?
"Patients of age 18 or older, but younger than 65 can enroll in this investigation."
Answered by AI
Am I a viable candidate to partake in this trial?
"Eligible applicants should have sustained a spinal cord injury and be between 18 to 65 years of age. A total of 18 participants will be accepted into this clinical trial."
Answered by AI
What is the estimated recruitment rate for this research study?
"Affirmative. The clinicaltrials.gov website shows that this research is open for enrollment, having been initially listed on February 1st 2023 and most recently updated on January 18th 2023. For the study to be completed successfully, it needs to find eighteen participants from a single medical centre."
Answered by AI
Is this trial currently enrolling participants?
"Affirmative. Details available on clinicaltrials.gov reveal that this experiment is actively accepting participants, which was initially posted on February 1st 2023 and recently updated January 18th 2023. The research requires the enlistment of 18 individuals from a single medical facility."
Answered by AI
Who else is applying?
What site did they apply to?
Brooks Rehabilitation Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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