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Behavioural Intervention
Spinal Stimulation + Buspirone for Paralysis
Phase < 1
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not taking anti-spasticity medications
Neurological level of injury below T1 and above T8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after each study phase, 1 year per group.
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-65 with stable spinal cord injuries (AIS grade A, B, or C) that occurred over a year ago. Participants must not be on anti-spasticity meds or MAO inhibitors and should have active responses in their lower spine to stimulation. Exclusions include those with certain health conditions like unhealed fractures, infections, severe diseases unrelated to the injury, pregnancy, drug abuse issues, and some medication interactions.Check my eligibility
What is being tested?
The study tests if non-invasive spinal stimulation combined with buspirone can help people with paralysis step using different supports: gravity-neutral devices, treadmills with body support, robotic exoskeletons by Ekso Bionics or rolling walkers. It's a five-year study involving 15 participants to find out which techniques work best.See study design
What are the potential side effects?
Possible side effects may include discomfort from the stimulation device; reactions to buspirone such as dizziness, nausea or headaches; muscle fatigue during physical training; skin irritation from equipment use; and potential interaction effects if other medications are taken.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on any medication for muscle stiffness.
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My spinal cord injury is between T1 and T8.
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My spinal cord injury is stable and classified as A, B, or C.
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My spinal cord injury is between T1 and T8.
Select...
My health condition is stable.
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I stopped taking monoamine oxidase inhibitors at least 2 weeks ago.
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I am between 18 and 65 years old.
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My spinal cord injury is stable and classified as AIS A, B, or C.
Select...
I am between 18 and 65 years old.
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It has been over a year since my injury.
Select...
I am not taking any medication for muscle stiffness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after each study phase, 1 year per group.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after each study phase, 1 year per group.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acoustic Gastro-Intestinal Surveillance, change over time
Assessment of verbal fluency, change over time
Bladder capacity, change over time
+13 moreSecondary outcome measures
Ashworth Scale, change over time
International Standards of Neurological Classification of Spinal Cord Injury, change over time
Spinal Cord
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Incomplete Spinal Cord Injury - Overground SteppingExperimental Treatment4 Interventions
Group 3 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. The first hour will be done in the Ekso overground and the second hour will use the rolling walker overground, both in the presence of stimulation. Afterwards, the second phase will include the same training procedures with the addition of Buspirone/placebo.
Group II: Complete Spinal Cord Injury - Gravity Neutral SteppingExperimental Treatment4 Interventions
Group 1 will begin with a 3-4-month preparation phase and up to 12 sessions in the gravity neutral device (GND) will occur. The training sessions in the GND will be used to obtain the optimal stimulation parameters. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. This will be done in the GND in the presence of stimulation. Afterwards, Intervention 2 will include the same training procedures with the addition of Buspirone or Placebo in a cross-over fashion halfway through this phase.
Group III: Complete Spinal Cord Injury - Exoskeleton Assisted SteppingExperimental Treatment4 Interventions
Group 2 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours in the Ekso overground, in the presence of stimulation and Buspirone/placebo. The second phase will include the same training procedures except for the removal of Buspirone/placebo administration. The third phase will include sessions twice per week in the Ekso overground with stimulation and one day per week using a rolling walker with stimulation. The last phase will include 2 sessions per week using the rolling walker and one day per week in the Ekso, both in the presence of stimulation and Buspirone/placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160
Body Weight Supported Treadmill Training
2006
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,969 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,375 Total Patients Enrolled
Alexander V Ovechkin, PhD5.03 ReviewsStudy Director - University of Louisville
University of Louisville
5Patient Review
Dr. Afanasyev's bedside manner is top-notch. He took the time to ensure that we fully understood the situation and what the next steps were. We no longer have to rely on ibuprofen, thanks to him.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
How old are they?
18 - 65
What site did they apply to?
Frazier Rehabilitation and Neuroscience Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
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