Your session is about to expire
← Back to Search
Transspinal Stimulation + Locomotor Training for Spinal Cord Injury
N/A
Recruiting
Led By Maria Knikou, PT, PhD
Research Sponsored by City University of New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, age 18-70 years old
Bone mineral density of the hip (proximal femur) T-score <3.5 SD from age- and gender-matched normative data
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will test the effects of adding electrical stimulation to locomotor training to help improve walking ability in people with Spinal Cord Injury.
Who is the study for?
This trial is for adults aged 18-70 with motor-incomplete spinal cord injury (SCI) above the T10 level, who can sign consent and commit to the study duration. They must be in good health, have a bone mineral density T-score <3.5 SD from norms, reflexes present for soleus H-reflex testing, flexible ankle joints without contractures, first-time SCI due to trauma or similar causes, and at least 6 months post-SCI.Check my eligibility
What is being tested?
The study tests if high-frequency noninvasive thoracolumbar spinal stimulation before locomotor training improves walking ability in people with incomplete SCI. Participants will receive either real or sham stimulation while lying down or standing before robotic gait training over 40 sessions.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation and fatigue from locomotor training. There's also a risk of seizures for those predisposed; however specific risks related to this intervention are not detailed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
My hip bone density is much lower than normal for my age and gender.
Select...
My spinal injury is above the T10 level.
Select...
I have a spinal cord injury that allows for some movement.
Select...
My spinal injury is above the middle of my back.
Select...
My ankles can move freely without stiffness.
Select...
I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.
Select...
My heart, lungs, and mind are in stable condition.
Select...
I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.
Select...
I have a spinal cord injury that allows me some movement.
Select...
My ankles can move freely without stiffness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasticity of corticospinal networks
Plasticity of spinal neuronal networks
Secondary outcome measures
Ambulatory function
Autonomic function
Balance
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Real transspinal stimulation delivered while lying supine followed by locomotor trainingExperimental Treatment1 Intervention
Transspinal tonic stimulation will be delivered at a frequency of 30 Hz while lying supine.
Group II: Real transspinal stimulation delivered during standing followed by locomotor trainingExperimental Treatment1 Intervention
Transspinal tonic stimulation of the thoracolumbar region will be delivered at a frequency of 30 Hz during standing with as needed body weight support (BWS) in a standing frame or in the Lokomat to ensure safety.
Group III: Sham transspinal stimulation delivered during standing followed by locomotor trainingPlacebo Group1 Intervention
One sham group will be receiving transspinal stimulation during standing at an intensity where sensation is absent.
Find a Location
Who is running the clinical trial?
City University of New YorkLead Sponsor
17 Previous Clinical Trials
5,608 Total Patients Enrolled
Bronx Veterans Medical Research Foundation, IncOTHER
9 Previous Clinical Trials
736 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
861 Previous Clinical Trials
525,231 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a spinal cord injury for more than 6 months.I have a history of seizures.I am not on medications that affect seizure risk.I am between 18 and 70 years old.You have had a spinal cord injury for more than 6 months.I am not currently part of any research study or new rehab program.I have a medical condition that could cause seizures.My hip bone density is much lower than normal for my age and gender.My spinal injury is above the T10 level.I have a spinal cord injury that allows for some movement.My spinal injury is above the middle of my back.I have a serious spine or spinal cord condition.My ankles can move freely without stiffness.I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.I have pressure sores.I have lesions above my spinal cord.I am willing and able to follow all study rules and attend all appointments.I have severe nerve pain or numbness.My heart, lungs, and mind are in stable condition.My spinal cord injury is classified as complete or sensory incomplete.I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.I have a severe urinary tract infection.My tendon reflexes are active enough for specific nerve testing.You have a cochlear implant, pacemaker, or any other implanted device that could be affected during the study.I have a tumor or blood vessel disorder in my spine or spinal cord.I have a spinal cord injury that allows me some movement.My ankles can move freely without stiffness.
Research Study Groups:
This trial has the following groups:- Group 1: Sham transspinal stimulation delivered during standing followed by locomotor training
- Group 2: Real transspinal stimulation delivered during standing followed by locomotor training
- Group 3: Real transspinal stimulation delivered while lying supine followed by locomotor training
Awards:
This trial has 0 awards, including: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.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04807764 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prerequisites for enrolling in this experiment?
"Participants are welcome to apply for this trial if they have sustained a spinal cord injury and are aged between 18-70 years old. Our team is anticipating 45 enrolments in total."
Answered by AI
Does this clinical exploration extend to those over the age of seventy?
"The parameters of this trial necessitate that participants must lie between the ages 18 and 70. Additionally, there are 41 trials available for minors while anyone above 65 has 327 options to choose from."
Answered by AI
What is the highest possible headcount of participants for this experiment?
"Confirmed. According to the information located on clinicaltrials.gov, this research is actively recruiting participants that meet the criteria for inclusion. Initially posted on August 1st 2021 and most recently edited on May 27th 2022, 45 people are being sought from 2 distinct locations."
Answered by AI
Is there currently room for participants to join this experiment?
"That is accurate. Per clinicaltrials.gov, this medical research project began recruiting on August 1st 2021 and the most recent edit was made on May 27th 2022. 45 participants are needed to be enrolled at two different trial locations."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
What site did they apply to?
Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I hope that science advance about spinal cord injuries. I started with oral baclofen but the side effects were bothering me too much so now I have the baclofen pump. I have tried plenty of muscle relaxers but I didn’t get the results I was hoping for.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger