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Neurostimulation Device
Epidural Spinal Cord Stimulation for Spinal Cord Injury (E-STAND 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
Intact segmental reflexes below the lesion of injury
Stable, motor-complete paraplegia
Must not have
Unhealed spinal fracture
Inability to withhold antiplatelet/anticoagulation agents perioperatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a way to improve epidural spinal cord stimulation for people with spinal cord injuries. The study will also look at how well autonomic function (such as blood pressure control) and other functions improve.
Who is the study for?
This trial is for adults over 22 with stable, motor-complete paraplegia due to spinal cord injury between C6 and T10. Participants must have had the injury for over a year, be medically stable, able to consent, and commit to all appointments. Excluded are those with certain health risks or conditions that complicate surgery or rehabilitation.
What is being tested?
The study tests optimizing epidural spinal cord stimulation settings to restore voluntary leg movement in people with paraplegia. It also looks at improvements in autonomic functions like blood pressure control related to spinal cord injuries.
What are the potential side effects?
While specific side effects aren't listed here, similar interventions may cause discomfort at the stimulation site, potential infection risk from surgery, and varying responses affecting blood pressure or reflexes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My reflexes below my injury site work.
Select...
I have stable paralysis affecting my lower limbs.
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My spinal cord injury is between my neck and mid-back.
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My spinal cord injury is classified as ASIA A or B.
Select...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a spinal fracture that has not yet healed.
Select...
I cannot stop taking my blood thinning medications for surgery.
Select...
I have a severe tightening of my skin or muscles.
Select...
I have frequent UTIs that antibiotics don't cure.
Select...
I don't have heart or lung problems that make spine surgery riskier.
Select...
I do not have severe nerve issues that prevent standing or a history of stroke or heart attack causing extreme blood pressure changes.
Select...
I can move my legs when asked during a muscle test.
Select...
I have pressure ulcers.
Select...
I have not had botulinum toxin injections in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Volitional Response Index Magnitude
Secondary study objectives
Cerebrovascular Assessment Change
Change in Visual Neurocognitive Assessment
Spinal cord stimulation for cardiovascular function
+1 moreAwards & 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: Epidural Spinal Cord StimulationExperimental Treatment1 Intervention
Epidural Spinal Cord Stimulation
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,858 Total Patients Enrolled
Minnesota Office of Higher EducationOTHER_GOV
4 Previous Clinical Trials
94 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
76 Previous Clinical Trials
354,685 Total Patients Enrolled
Hennepin County Medical Center, MinneapolisOTHER
21 Previous Clinical Trials
12,220 Total Patients Enrolled
Hennepin Healthcare Research InstituteOTHER
92 Previous Clinical Trials
77,093 Total Patients Enrolled
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My reflexes below my injury site work.I need opioids for pain or have pain that might stop me from fully joining in the rehab program.I have stable paralysis affecting my lower limbs.I have a spinal fracture that has not yet healed.My spinal cord injury is between my neck and mid-back.My spinal cord injury is classified as ASIA A or B.I cannot stop taking my blood thinning medications for surgery.I have a severe tightening of my skin or muscles.I have frequent UTIs that antibiotics don't cure.I am 22 years old or older.I don't have heart or lung problems that make spine surgery riskier.I do not have severe nerve issues that prevent standing or a history of stroke or heart attack causing extreme blood pressure changes.It's been over a year since my injury and 6 months since any spinal surgery.I can move my legs when asked during a muscle test.I have pressure ulcers.I have not had botulinum toxin injections in the last 6 months.