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Procedure

Epidural Stimulation + Training for Spinal Cord Injury (MC-PP-3 Trial)

N/A

Recruiting

Research Sponsored by Susan Harkema PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

unable to voluntarily move all individual joints of the legs

Bladder dysfunction as a result of SCI

Must not have

Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI

Ventilator dependent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 80 sessions, approximately 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether epidural stimulation can help people with spinal cord injuries walk and improve their bladder function.

Who is the study for?

This trial is for adults over 18 with a stable, non-progressive spinal cord injury (SCI) between T1 and T10. They must be within one year post-injury, unable to stand or walk independently, have bladder dysfunction due to SCI, and not on anti-spasticity meds or received botox in the last six months. Excluded are those ventilator-dependent, with untreated major health issues or psychiatric disorders/drug abuse.

What is being tested?

The study tests if epidural stimulation can improve standing, walking, and bladder functions in people with acute SCI. Participants will undergo different training protocols: Bladder Capacity Training, Bladder Voiding Efficiency Training, Step Training or Stand Training alongside the epidural stimulation.

What are the potential side effects?

While specific side effects aren't listed here for this intervention type; generally speaking such procedures may cause discomfort at the stimulation site, potential infection risk from surgery and possible nerve irritation.

Eligibility Criteria

Inclusion Criteria

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

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I cannot move all the joints in my legs on my own.

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I have bladder problems due to a spinal cord injury.

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I am not taking any medication for muscle stiffness.

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I cannot move all the joints in my legs on my own.

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My spinal cord injury is between the T1 and T10 vertebrae.

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I cannot stand or walk on my own.

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I am not currently taking any medication for muscle stiffness.

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My spinal cord injury is not getting worse.

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I am 18 years old or older.

Exclusion Criteria

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

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I have heart, lung, bladder, or kidney conditions not caused by my spinal cord injury.

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I rely on a machine to help me breathe.

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I have untreated painful bone or muscle issues, fractures, or pressure sores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 80 sessions, approximately 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~80 sessions, approximately 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 80 sessions, approximately 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ambulation

Bladder storage/voiding

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: LocomotionExperimental Treatment2 Interventions

Participants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.

Group II: Bladder+LocomotionExperimental Treatment4 Interventions

Participants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.

0 / 12Eligibility criteria met