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Spinal Stimulation + Buspirone for Paralysis
Study Summary
This trial will be testing the combination of noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in order to help facilitate locomotor activity in people with paralysis due to severe spinal cord injury. The goal is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants who are at least one year post-injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am not on any medication for muscle stiffness.My spinal cord injury is between T1 and T8.I currently have an untreated urinary tract infection.I have nerve damage in my legs.My spinal cord injury is stable and classified as A, B, or C.I am healing from spine surgery between my mid-back and lower back.My spinal cord injury is between T1 and T8.I have nerve damage in my hands or feet.My health condition is stable.I am not taking any medication that interacts with Buspirone.Your Creatinine Clearance levels are higher than normal.You have serious depression, mental health issues, or are currently abusing drugs.I have heart or lung disease not caused by my spinal cord injury.I stopped taking monoamine oxidase inhibitors 2 weeks ago.I stopped taking monoamine oxidase inhibitors at least 2 weeks ago.I have a bone fracture that hasn't healed.You have ongoing nerve activity in your lower back and spine.I have been diagnosed with osteoporosis.I am between 18 and 65 years old.You have ongoing responses in your lower back and legs when stimulated in the spinal cord.My spinal cord injury is stable and classified as AIS A, B, or C.I am between 18 and 65 years old.It has been over a year since my injury.I have anemia.I have a metal implant in my leg.I experience pain in my muscles or joints.I have a seizure disorder.My liver function tests are abnormal.You have a pump implanted to treat muscle stiffness.I have active pressure sores.You have a catheter implanted in your abdomen.I had leg injuries or disorders before or at the same time as my spinal injury.I am not taking any medication for muscle stiffness.You rely on a ventilator to help you breathe.You have uncontrolled autonomic dysreflexia.I have tightness in my legs that limits movement.I need help with daily activities and cannot stand on my own.
- Group 1: Complete Spinal Cord Injury - Exoskeleton Assisted Stepping
- Group 2: Complete Spinal Cord Injury - Gravity Neutral Stepping
- Group 3: Incomplete Spinal Cord Injury - Overground Stepping
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are new participants accepted in this trial?
"Affirmative. According to the clinicaltrials.gov entry, this medical research project is presently recruiting participants since it was initially posted in September 2019 and updated lastly on July 11th 2022. 15 volunteers are required across one location."
What is the purpose of this clinical investigation?
"The primary endpoints used to measure the efficacy of this clinical trial are changes in Voluntary Lower Extremity Angles over time, observed before and after each study phase which spans 1 year per group. Additionally, [Spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) Functional Ambulation Inventory (a 3-part scale measuring gait parameters), Walking Index for Spinal Cord Injury-II (used to assess physical assistance needed during walking) as well Ashworth Scale( a 6-part scale that gauges muscle tone when joints move through full range of motion) will be tracked as secondary metrics."
Does my medical history meet the criteria for participation in this clinical investigation?
"Aspiring participants must possess a spinal cord injury and be of lawful age (18-65) to meet the enrollment criteria for this study. A maximum of 15 clinical trial members will be accepted in total."
Are participants over the age of fifty eligible for this research?
"This clinical trial is open to adult participants aged 18 or older and younger than 65."
What other studies have been conducted to analyze the efficacy of Non-invasive Spinal Cord Stimulation?
"At present, nine research projects that investigate Non-invasive Spinal cord Stimulation are in operation with none of them having reached Phase 3. While the majority of these clinical studies take place in Tianjin, there is a total of 9 trial sites worldwide."
How many participants have joined this experiment thus far?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical study is proceeding with recruitment. Initially posted on September 30th 2019 and most recently updated July 11th 2022, it aims to recruit 15 participants from 1 site across the nation."
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