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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

Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)

At least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My spinal cord injury is stable and between the C3 and T1 vertebrae.

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I am 18 years old or older.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Maximum Expiratory Pressure (PEmax)

Change in Maximum Inspiratory Pressure (PImax)

Change in Surface electromyography (sEMG) Magnitude (Mag)

+1 more

Secondary outcome measures

Change in Baroreflex Effectiveness Index (BEI)

Change in Baroreflex sensitivity (BRS)

Change in Forced Expiratory Volume in 1 second (FEV1)

+1 more

Other outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,954 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,605 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, Spinal Cord Stimulation and Respiratory Training, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left to participate in this clinical exploration?

"According to clinicaltrials.gov, this investigation into a potential medical intervention is currently in search of volunteers; it was first announced on the last day of 2021 and had its most recent update 21 days later."

Answered by AI

What is the desired outcome of this experiment?

"This clinical trial seeks to assess Maximum Expiratory Pressure (PEmax) at its conclusion. Secondary endpoints include Baroreflex Sensitivity (BRS), Baroreflex Effectiveness Index (BEI), and Forced Vital Capacity (FVC). All of these objectives will be evaluated over the duration of one year."

Answered by AI

What is the current patient census of this clinical experiment?

"Affirmative. Research on clinicaltrials.gov suggests that this investigation is actively seeking participants, having initially been posted online December 31st 2021 and revamped January 21st 2022. The trial requires 30 patients at one single location to participate in the process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Stimulation and Respiration After Injury

Alexander V Ovechkin, MD, PhD 2021. "Spinal Cord Stimulation and Respiration After Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05178056.

All > Spinal Cord Injury