← Back to Search

Behavioural Intervention

Spinal Cord Stimulation + Respiratory Training 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

No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation

At least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.

Awards & highlights

Study Summary

This trial studies how spinal cord stimulation can improve respiratory function in patients with chronic spinal cord injury, combining it with respiratory training.

Who is the study for?

This trial is for adults over 18 with chronic spinal cord injury (SCI) who have been stable for at least a year and show significant breathing function deficits. It's not suitable for those dependent on ventilators, with major illnesses like heart disease or cancer, obesity, pregnancy, or conditions that could interfere with the training.Check my eligibility

What is being tested?

The study tests if non-invasive spinal cord stimulation combined with respiratory training can improve lung function in SCI patients. Participants are divided into three groups to receive either just the training, just the stimulation, or both together.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation and fatigue from respiratory exercises. However, specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I don't have any major muscle or bone issues, open wounds, or UTIs that could affect my breathing exercises.

Select...

I am 18 years old or older.

Select...

My spinal cord injury hasn't worsened and I don't need a ventilator. My injury level is above T5 and classified as 'A' or 'B'.

Select...

I had a spinal cord injury over a year ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Expiratory Pressure (PEmax).

Maximum Inspiratory Pressure (PImax).

Surface electromyography (sEMG) Similarity Index (SI)

Secondary outcome measures

Baroreflex blood pressure effectiveness index (BEI).

Baroreflex blood pressure sensitivity (BRS).

Baroreflex heart rate effectiveness index (BEI).

+4 more

Other outcome measures

The Craig Handicap Assessment & Reporting Technique (CHART) Questionnaire.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Spinal Cord Transcutaneous Stimulation and Respiratory Training (scTS+RT) groupExperimental Treatment2 Interventions

Participants will undergo 80 scTS combined with the RT while seated in their own wheelchairs with an approximately 45° head-up tilt. The scTS will be administered using the Neostim/Biostim (Cosyma Inc., Denver CO) and Standard threshold Positive Expiratory Pressure Device (PEP, Respironics Inc., Cedar Grove, NJ) and standard threshold Inspiratory Muscle Trainer (IMT, Respironics Inc., Cedar Grove, NJ) assembled together using a T-shaped connector with a flanged mouthpiece (Airlife 001504) will be used for the RT as described for the Arms 1 and 2.

Group II: Training (RT) groupActive Control1 Intervention

80 scTS sessions will be administered using the Neostim/Biostim (Cosyma Inc., Denver CO) device applying up to five conductive electrodes placed on the skin at the midline over the thoracic levels as cathodes between T1 to T8, and up to four self-adhesive electrodes located symmetrically on the skin over the iliac crests and shoulders as anodes. During the intervention, optimally configured scTS will be delivered based on the measures assessed during mapping sessions. The scTS with 5 mA-sub-motor threshold intensity with optimal frequency and pulse width will be delivered using 5 min on and 5 min off stimulation periods during interventional bouts. Every research participant will be slowly acclimated to stimulation. Blood pressure, heart rate, and respiratory rate will be closely monitored throughout stimulation sessions in the Lab by using beat-to-beat blood pressure, and respiratory kinematics monitoring.

Group III: Spinal Cord Transcutaneous Stimulation (scTS) groupActive Control1 Intervention

Participants will undergo 80 RT sessions using standard threshold Positive Expiratory Pressure Device (PEP, Respironics Inc., Cedar Grove, NJ) and standard threshold Inspiratory Muscle Trainer (IMT, Respironics Inc., Cedar Grove, NJ) assembled together using a T-shaped connector with a flanged mouthpiece (Airlife 001504). Participants will be trained at the Frazier Rehab Institute and remotely to complete eighty 45-minute sessions during 16 weeks. The participants will be instructed to perform inspiratory and expiratory efforts against a pressure threshold load. The training will be initiated with a load equal to 20% of their individual Maximum Inspiratory Pressure (PImax) and Maximum Expiratory Pressure (PEmax) values with progressive increases as tolerated up to 60% of their baseline PImax and PEmax measures. The goal will be to reach the 60% load of PImax and PEmax during the last week of each month of the training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Respiratory Training

2020

N/A

~90

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,644 Total Patients Enrolled

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

3,839 Previous Clinical Trials

47,851,968 Total Patients Enrolled

Alexander Ovechkin, MD, PhDPrincipal InvestigatorUniversity of Louisville

3 Previous Clinical Trials

126 Total Patients Enrolled

Frequently Asked Questions

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

Is the recruitment phase of this clinical trial still open?

"According to clinicaltrials.gov, recruitment for this trial has concluded and the study is no longer enrolling individuals at this time. Initial postings occurred on September 10th 2023 with the most recent update taking place August 25th of that same year. Despite having closed enrolment for this particular medical investigation, there are still 1,038 other studies actively recruiting patients across various locations."

Answered by AI

What are the aims of this medical experiment?

"This clinical trial aims to determine the upper limit of Maximum Inspiratory Pressure (PImax) over a period spanning 8 weeks. Additionally, Secondary objectives include Forced Expiratory Volume in 1 second (FEV1), Baroreflex Blood Pressure Sensitivity (BRS), and Baroreflex Heart Rate Sensitivity (BRS). All assessments are made through Standard Spirometry Measurements and Valsalva Maneuvers respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury

Alexander V Ovechkin, MD, PhD 2023. "Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06019949.