Epidural Stimulation for Spinal Cord Injury

(TSEPI Trial)

Overseen by Susan J Harkema, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses electrical stimulation of the lower spinal cord to help people with severe spinal cord injuries who can't move their legs or stand. The electrical signals aim to reactivate nerves, improving movement and other bodily functions. Electrical stimulation of the spinal cord has been used for pain relief, spasticity control, and movement restoration in spinal cord injury patients.

Research Team

Susan J Harkema, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for adults over 18 with severe spinal cord injury, unable to stand or move legs voluntarily, and experiencing issues like low blood pressure and respiratory dysfunction. They should be at least two years post-injury with stable health but can't join if they use nicotine, have certain implants, untreated conditions, or are pregnant.

Inclusion Criteria

I am 18 years old or older.

My spinal cord injury is not getting worse.

It has been over 2 years since my injury.

Exclusion Criteria

I have not had bladder botox injections in the last year.

You require a machine to help you breathe.

You currently have an untreated mental health disorder or are actively using drugs.

Treatment Details

Interventions

• Epidural Stimulation (Procedure)
• Stand Training (Behavioural Intervention)

Trial Overview The study tests how epidural stimulation (scES) helps recover functions affected by spinal cord injuries. Participants will receive scES aimed at improving cardiovascular function, voluntary movement of legs/trunk, or standing ability. The impact on quality of life and healthcare costs will also be evaluated.

Participant Groups

Group I: Voluntary Movement ES + Stand Training Experimental Treatment 1 Intervention

Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.

Group II: Epidural Stimulation for Voluntary Movement Experimental Treatment 1 Intervention

Participants assigned to this group receive epidural stimulation specifically for voluntary movement.

Group III: Epidural Stimulation for Cardiovascular stability during daily activities Experimental Treatment 1 Intervention

Participants assigned to this arm will receive be randomized to receive epidural stimulation specific for cardiovascular function alone or cardiovascular function and standing, or voluntary movement alone or voluntary movement and standing.

Group IV: Cardiovascular ES + Stand Training Experimental Treatment 1 Intervention

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.

Group V: Acute Epidural Stimulation for Cardiovascular Stability. Experimental Treatment 1 Intervention

Participants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia.

Epidural Stimulation is already approved in Canada for the following indications:

Approved in Canada as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Christopher Reeve Paralysis Foundation

Collaborator

Trials

6

Recruited

1,800+