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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
No Placebo-Only Group

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 below
Select...
I have had a spinal cord injury for at least 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

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 more
Secondary study objectives
Change in Baroreflex Effectiveness Index (BEI)
Change in Baroreflex sensitivity (BRS)
Change in Forced Expiratory Volume in 1 second (FEV1)
+1 more
Other study objectives
Changes in Spinal Cord Independence Measure (SCIM) scores
Changes in The Craig Handicap Assessment & Reporting Technique (CHART) scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
348 Previous Clinical Trials
77,348 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,913 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

Respiratory Training Clinical Trial Eligibility Overview. Trial Name: NCT05178056 — N/A
Rehabilitation Research Study Groups: Spinal Cord Stimulation and Respiratory Training, Spinal Cord Stimulation, Respiratory Training
Rehabilitation Clinical Trial 2023: Respiratory Training Highlights & Side Effects. Trial Name: NCT05178056 — N/A
Respiratory Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05178056 — N/A
~8 spots leftby Feb 2026
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