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Electrical Stimulation

Non-Invasive Spinal Cord Stimulation for Spinal Cord Injury

N/A

Waitlist Available

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

Must not have

Unhealed fracture

Untreated musculoskeletal dysfunction

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 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.

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.

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 below

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My lung function tests show healthy breathing capacity.

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I am 21 years old or older.

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I am 18 years old or older.

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My spinal cord injury is above T5 and not getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bone that hasn't healed yet.

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I have not received treatment for a muscle or joint problem.

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I have a contracture or pressure sore that hasn't been treated.

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I have a significant disease affecting my esophagus or digestive system.

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I rely on a machine to help me breathe.

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I have a serious lung or heart condition.

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I have a history of heart disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum airway pressure

Non-invasive respiratory electromyography

Spirometry

Secondary study objectives

Aerobic Endurance Test (VO2Peak)

Beat-by-beat arterial blood pressure

Functional Neurophysiological Assessment (FNPA)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 11Eligibility criteria met