Long-term Follow-up for Epidural Stimulation in SCI

NCT07042815 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: R-1273-24
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to:

• receive stimulation programs and software for the activities and/or functions completed in the previous study and demonstrate to the research staff that I can conduct them without their help to use at home
• continue using the stimulation programs at home as directed by the research staff
• return to Kessler Foundation for a follow-up visit (approx. 2 hours) with assessments at 6 months, 1 year, and once a year after enrolled in the follow-up study last until either the device is turned off, removed or the device is commercially approved.

Conditions

SCI - Spinal Cord Injury

Keywords

spinal stimulation; epidural

Outcome Measures

Primary Outcomes (3)

• Motor Control Assessments with stimulation

  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.

  On average, 1 hour each visit completed 6 months, 1 year, and yearly

• Bladder Function Assessment

  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.

  on average, 30 minutes each visit completed 6 months, 1 year, and yearly

• Cardiovascular Assessment

  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.

  24 hours prior to visit, completed 6 months, 1 year, and yearly

Secondary Outcomes (3)

• Questionnaires

  On average, 30 minutes each visit completed 6 months, 1 year, and yearly

• Imaging Assessments

  On Average, 15 minutes each visit completed 6 months, 1 year, and yearly

• Spasticity Monitoring

  Each visit completed 6 months, 1 year, and yearly

Study Arms (1)

Home Use and Follow-Up Visit Group

EXPERIMENTAL

Participants will be cleared by study staff for home-use of the stimulation programs they received in the previous study. Participants will then follow and log the programs according to study staff recommendations.

Device: Epidural Stimulation Programs

Interventions

Epidural Stimulation Programs DEVICE

Epidural stimulations will accompany stimulation programs that have been established during research visits in the prior study and have been recommended by the clinical research team for use in the home and community. Stimulation programs will be given for activities (such as standing or walking) and/or responses that were completed in the previous study. This will be continued until the device is removed or approved for commercial use.

Home Use and Follow-Up Visit Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Tim and Caroline Reynolds Center for Spinal Stimulation

Model Details: Participants will receive the same stimulation programs and assessments as they did during the previous study they were enrolled in. This model is tracking the participant longitudinally at di intervals of 6 months and 1 year.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 29, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)