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Electrical Stimulation

Spinal Cord Stimulation for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Peter J. Grahn, Ph.D.

Eligibility Criteria Checklist

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

Must have

At least 22 years of age

Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae

Must not have

Active, untreated urinary tract infection

Undergoing, or planning to undergo, diathermy treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up rehabilitation day 1, rehabilitation day 10

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare electrical stimulation of the spinal cord vs. a cluster of nerves at the base of the spine, and measure the effects on motor skills after 10 sessions.

Who is the study for?

This trial is for adults over 22 with spinal cord injuries from trauma above the tenth thoracic vertebrae, at least one year post-injury. They must have certain levels of injury severity (ASIA A-D) and intact reflexes below the injury. Women should agree to use contraception. Exclusions include pregnancy, unhealed wounds, non-MRI-compatible devices, active trials participation, seizures, severe health conditions affecting protocol adherence or safety.

What is being tested?

The study tests two types of stimulation: epidural and dorsal root ganglion stimulation in individuals with spinal cord injuries. Over ten rehab sessions, it measures changes in motor performance and electrical activity within the spine to see which method might be more effective.

What are the potential side effects?

While specific side effects are not listed here, procedures involving epidural or dorsal root stimulation may cause discomfort at the site of electrode implantation, potential infection risk from invasive procedures and possible nerve irritation or damage.

Eligibility Criteria

Inclusion Criteria

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

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I am 22 years old or older.

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My spinal cord injury is above my waist.

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My spinal reflexes are working below my spinal cord injury.

Exclusion Criteria

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

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I currently have a urinary tract infection that hasn't been treated.

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I am planning to have or currently undergoing diathermy treatment.

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I have an open sore that has not healed.

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I have a history of seizures.

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I have a bone fracture that hasn't healed.

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I have a psychiatric disorder that has not been treated.

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I have stiff joints that limit my movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ rehabilitation day 1, rehabilitation day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~rehabilitation day 1, rehabilitation day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and rehabilitation day 1, rehabilitation day 10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Balance (1)

Balance [as appropriate to the subject] (2)

Electromyography

+17 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Percutaneous ES and DRSExperimental Treatment1 Intervention

Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

0 / 10Eligibility criteria met