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NCT07042815

Long-term Follow-up for Epidural Stimulation in SCI

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
Kessler Foundation
~91 participants
Updated 2025-06-29 on ClinicalTrials.gov
What's tested:Epidural Stimulation Programs

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Motor Control Assessments with stimulation
Measured over On average, 1 hour each visit completed 6 months, 1 year, and yearly
+2 more outcomes measured

Conditions

SCI - Spinal Cord Injury

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

at least 18 years of age
have a spinal cord injury that is not getting worse
received a neurostimulator and electrode array as part of a previous study
choose to continue epidural stimulation in the home and community
have completed a previous IRB approved epidural stimulation study at a participating research site

Exclusion

heart, lung, bladder, kidney or other untreated medical disorder unrelated to SCI
choose not to use the epidural stimulation as recommended by the investigators
withdrawn from the main epidural stimulation study or made the choice to remove the stimulator/return the controller to the site
new surgeries, diagnoses, or other changes in status since completion of main epidural study that may affect the ability to complete assessments
Unable to undergo an MRI
Conditions that may make me ineligible for transcranial magnetic stimulation (a kind of brain stimulation through the skin)

What this trial measures

  • Motor Control Assessments with stimulationOn average, 1 hour each visit completed 6 months, 1 year, and yearly

    Participants will receive epidural stimulation and motor tasks based on their prior study participations' assessments and programming. During this stimulation, participants will be given motor tasks that may involve sitting, standing, stepping, and movement of their extremities. Electrodes will be placed over the specific muscles measured in that motor task. Data from those electrode readings will be transferred to numerical data. Plots from that numerical data will be created by identifying amplitude against stimulation intensity and threshold intensity, rate of recruitment, and plateau intensity per muscle using customized MATLAB software and then compared to results in the participants' prior training study.

  • Bladder Function Assessmenton average, 30 minutes each visit completed 6 months, 1 year, and yearly

    This assessment will only be performed in the participants who previously completed the locomotor, bladder and bowel intervention study (R-1230-23) The bladder function assessment includes a urinalysis and bladder pressure test. The bladder pressure test involves emptying of the bladder and refilling with saline with a catheter that measures bladder pressure. Urinalysis is to screen for bacteria. Results will be recorded and compared with previous study data.

  • Cardiovascular Assessment24 hours prior to visit, completed 6 months, 1 year, and yearly

    Participant blood pressure will be monitored over a 24-hour period outside the lab with a blood pressure monitor provided by the lab and during visit assessments. The reading will be recorded and compared to prior study readings.