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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rehabilitation day 1, rehabilitation day 10
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Balance (1)
Balance [as appropriate to the subject] (2)
Electromyography
+17 more

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.

Find a Location

Who is running the clinical trial?

Peter J. Grahn, Ph.D.Lead Sponsor

Media Library

Spinal Cord Injury Research Study Groups: Percutaneous ES and DRS

Frequently Asked Questions

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

What is the present enrollment size of this experiment?

"Affirmative. According to information available on clinicaltrials.gov, this research project is currently recruiting volunteers. The trial was initially published on September 24th 2021 and the most recent update took place October 4th 2022; 32 participants must be recruited at a single medical facility."

Answered by AI

Which participants is this experiment currently recruiting?

"Affirmative. According to clinicaltrials.gov, this examination is actively looking for volunteers; the trial was initially listed on September 24th 2021 and recently updated on October 4th 2022. 32 patients need to be enrolled from 1 medical site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Ohio
Colorado
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
Peter J. Grahn, Ph.D. 2021. "Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04736849.
All > Spinal Cord Injury > Sci
~11 spots leftby Oct 2025
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