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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
Sustained SCI at least 24 months prior to entering the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
Summary
This trial is studying whether electrical stimulation of the spinal cord can improve respiratory function in patients with chronic spinal cord injury.
Who is the study for?
This trial is for adults over 18 with stable, non-progressive spinal cord injuries between C3-T1, who have had the injury for at least two years and have a significant deficit in lung function. It's not suitable for those with severe musculoskeletal pain, unhealed fractures, contractures, active infections or major cardiovascular diseases among other exclusions.
What is being tested?
The study tests how well electrical stimulation of the spine combined with breathing exercises can help control breathing in people with chronic spinal cord injuries. It aims to find specific stimulation settings that improve neural responses and promote recovery of respiratory functions.
What are the potential side effects?
While the description doesn't specify side effects, similar interventions may cause discomfort at the stimulation site, muscle spasms or skin irritation from electrodes used during electromyography.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a spinal cord injury for at least 2 years.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Maximum Expiratory Pressure (PEmax)
Change in Maximum Inspiratory Pressure (PImax)
Change in Surface electromyography (sEMG) Magnitude (Mag)
+1 moreSecondary study objectives
Change in Baroreflex Effectiveness Index (BEI)
Change in Baroreflex sensitivity (BRS)
Change in Forced Expiratory Volume in 1 second (FEV1)
+1 moreOther study objectives
Changes in Spinal Cord Independence Measure (SCIM) scores
Changes in The Craig Handicap Assessment & Reporting Technique (CHART) scores
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Spinal Cord Stimulation and Respiratory TrainingExperimental Treatment2 Interventions
Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.
Group II: Spinal Cord StimulationActive Control1 Intervention
Research subjects with implanted stimulator undergoing stimulation intervention.
Group III: Respiratory TrainingActive Control1 Intervention
Research subjects with no implanted stimulator undergoing RT intervention.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,303 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,177 Total Patients Enrolled
1 Trials studying Rehabilitation
54 Patients Enrolled for Rehabilitation
Alexander Ovechkin, MD, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant hormone-related condition.My spinal cord injury is stable and between the C3 and T1 vertebrae.I have an illness related to HIV/AIDS.I do not have any major illnesses that would prevent me from doing breathing exercises.My health condition is stable.I am significantly overweight.I have had a deep vein thrombosis.I experience pain in my muscles or joints.I have a significant heart condition.I have been diagnosed with severe depression.I have been diagnosed with cancer.I have a bone that hasn't healed yet.I have tightness in my joints or muscles.I have a pressure sore.I have a urinary tract infection that could affect my breathing exercises.I have significant issues with my digestive system.I am 18 years old or older.I have other health issues affecting my breathing.I have a significant lung condition.I have had a spinal cord injury for at least 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation and Respiratory Training
- Group 2: Spinal Cord Stimulation
- Group 3: Respiratory Training
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.
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