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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Awards & highlights

E-STAND Trial 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.Check my eligibility

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.See study design

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.

E-STAND Trial Eligibility Criteria

Inclusion Criteria

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

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My reflexes below my injury site work.

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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.

E-STAND Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 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 Response Index Magnitude

Secondary outcome measures

Cerebrovascular Assessment Change

Change in Visual Neurocognitive Assessment

Spinal cord stimulation for cardiovascular function

+1 more

E-STAND Trial Design

1Treatment groups

Experimental Treatment

Group I: Epidural Spinal Cord StimulationExperimental Treatment1 Intervention

Epidural Spinal Cord Stimulation

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,380 Previous Clinical Trials

1,588,645 Total Patients Enrolled

Minnesota Office of Higher EducationOTHER_GOV

4 Previous Clinical Trials

94 Total Patients Enrolled

Minneapolis Veterans Affairs Medical CenterFED

72 Previous Clinical Trials

14,820 Total Patients Enrolled

Media Library

Epidural Spinal Cord Stimulation (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03026816 — N/A

Frequently Asked Questions

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

Is this investigation currently accepting participants?

"Clinicaltrials.gov illustrates that this research study is still recruiting participants, which began on August 7th 2017 and was most recently revised on April 26th 2022."

Answered by AI

How many participants are being registered to join this clinical experiment?

"Affirmative. The records on clinicaltrials.gov reveal this trial, which was first posted on August 7th 2017, is still recruiting participants. This study requires 100 patients from a single medical centre to take part in it."

Answered by AI