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Neurostimulation Device

Epidural Stimulation for Spinal Cord Injury (LTO Trial)

N/A
Recruiting
Led By David Darrow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

LTO Trial Summary

This trial will study how spinal cord stimulation can restore movement in people with spinal cord injury over time.

Who is the study for?
This trial is for adults over 22 with stable spinal cord injuries, who are not ventilator-dependent and have an existing, working FDA-approved spinal cord stimulator. They should be medically stable and at least a year out from their initial injury. Those with certain levels of impairment (AISA 'A' or 'B'), no recent Botox treatments, and not on opioid pain meds that would limit rehab participation can join.Check my eligibility
What is being tested?
The study tests the long-term effects of chronic epidural spinal cord stimulation in restoring voluntary movement in patients with chronic spinal cord injuries. It aims to understand how this treatment helps over time.See study design
What are the potential side effects?
While specific side effects are not listed here, epidural stimulation may include risks such as discomfort at the stimulation site, potential infection risk from surgery, nerve damage, or changes in blood pressure.

LTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Volitional electromyography (EMG) power
Secondary outcome measures
Prediction of power preferences

LTO Trial Design

1Treatment groups
Experimental Treatment
Group I: Volitional EMG powerExperimental Treatment1 Intervention
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,925 Total Patients Enrolled
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

Epidural Spinal Cord Stimulation (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05705453 — N/A
Spinal Cord Injury Research Study Groups: Volitional EMG power
Spinal Cord Injury Clinical Trial 2023: Epidural Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT05705453 — N/A
Epidural Spinal Cord Stimulation (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705453 — N/A

Frequently Asked Questions

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

Is enrollment for this experiment open to participants?

"Reportedly, clinicaltrials.gov does not have this trial listed as actively recruiting participants at the moment. This research project was initially unveiled on March 1st 2023 and its last update occurred in January of 2023. However, there are presently 353 other studies that can be accessed by interested patients."

Answered by AI

Who else is applying?

What site did they apply to?
Hennepin County Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have improved plenty sin e my injury. I know that a treatment like this and my training ethics would boost my recovery immensely.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
2023. "Epidural Stimulation After Neurologic Damage: Long-Term Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705453.
~33 spots leftby Apr 2033
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