Your session is about to expire
← Back to Search
Electrical Stimulation
Non-Invasive Spinal Cord Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Alexander Ovechkin, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
FVC and FEV1 values 80% of predicted or above indicating healthy pulmonary function by screening spirometry
At least 21 years of age at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
Study Summary
This trial is testing different ways to help people with spinal cord injuries breathe better. It will compare task-specific training (like respiratory or arm exercises) with non-task-specific stimulation (like electrical stimulation of the spinal cord) to see which is more effective.
Who is the study for?
This trial is for adults with stable, non-progressive spinal cord injuries at T5 or above, who've had the injury for over a year and have reduced lung function. It's not suitable for those with untreated musculoskeletal issues, fractures, contractures, sores, ventilator dependence, severe mental health issues or substance abuse problems.Check my eligibility
What is being tested?
The study tests how different combinations of respiratory training and electrical stimulation affect lung and muscle function in people with spinal cord injuries. The effectiveness of these therapies will be measured by changes in lung capacity and trunk muscle performance.See study design
What are the potential side effects?
While specific side effects are not detailed here, transcutaneous electrical spinal cord stimulation may cause discomfort or skin irritation where the electrodes are placed. Muscle fatigue could also occur from the training exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function tests show healthy breathing capacity.
Select...
I am 21 years old or older.
Select...
I am 18 years old or older.
Select...
My spinal cord injury is above T5 and not getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum airway pressure
Non-invasive respiratory electromyography
Spirometry
Secondary outcome measures
Aerobic Endurance Test (VO2Peak)
Beat-by-beat arterial blood pressure
Functional Neurophysiological Assessment (FNPA)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Spinal Cord Injured (SCI) intervention groupsExperimental Treatment1 Intervention
The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT.
Group II: Non-Disabled (ND) and Spinal Cord Injured (SCI) controlsExperimental Treatment1 Intervention
The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention. The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS. The investigators will decide which stimulation type should be used for the post-mapping assessments.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,644 Total Patients Enrolled
Alexander Ovechkin, MD, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function tests show healthy breathing capacity.You have not received treatment for depression, have a mental health condition, or are currently using drugs excessively.I am 21 years old or older.I have a bone that hasn't healed yet.I have not received treatment for a muscle or joint problem.I have a contracture or pressure sore that hasn't been treated.I am not disabled and meet the study's gender criteria.You have had a spinal cord injury for at least 12 months before joining the study.I have a significant disease affecting my esophagus or digestive system.You have a hormone disorder, cancer, severe obesity, blood clot in a deep vein, or a disease related to HIV/AIDS.I have conditions like anemia or nerve issues causing my dizziness when standing.Your lung function test shows at least a 15% decrease in breathing capacity.I am 18 years old or older.My health condition is stable.I have a history of lung or breathing problems.My selection for the SCI study does not depend on my gender.My spinal cord injury is above T5 and not getting worse.I rely on a machine to help me breathe.I have a serious lung or heart condition.I have a history of heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Disabled (ND) and Spinal Cord Injured (SCI) controls
- Group 2: Spinal Cord Injured (SCI) intervention groups
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.
What are the primary objectives of this medical experiment?
"This medical trial, which is slated to run for approximately one year, seeks to assess non-invasive respiratory electromyography. Secondary objectives include beat-by-beat arterial blood pressure monitoring, functional neurophysiological assessment of motor capacity and control in the upper and lower extremities/trunk, as well as evaluation of handicap using the Craig Handicap Assessment & Reporting Technique (CHART) questionnaire."
Answered by AI
Is it possible for me to register in this clinical experiment?
"The investigators of this medical study are looking for 36 volunteers between 18 and 99 years old who have experienced a spinal cord injury. To qualify, applicants must be above the legal age at enrollment, with their condition having remained stable since sustaining their SCI no less than 12 months ago. Additionally, they must demonstrate an FVC or FEV1 deficit of 15% or higher as observed during screening spirometry."
Answered by AI
Are there any opportunities to join this research experiment at present?
"Clinicaltrials.gov data suggests that this trial, which was initially posted on May 24th 2023, is not actively recruiting at present. However, 352 other studies are currently searching for volunteers."
Answered by AI
Is the upper-age limit for this clinical trial restricted to individuals aged 85 and below?
"This clinical trial is only available to those between 18 and 99 years of age. There are 37 additional studies for minors, as well as 306 trials designed specifically for seniors."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger