SCI - Spinal Cord InjuryNCT07042815
Long-term Follow-up for Epidural Stimulation in SCI
A study testing Epidural Stimulation Programs in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial 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: 1. provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Epidural Stimulation Programs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- withdrawn from the main epidural stimulation study or made the choice to remove the stimulator/return the controller to the site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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi Site Long-term Follow-up for Those With Experimental Epidural Stimulation After Severe Spinal Cord Injury
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:
- provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life
- provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel
- collect long-term safety data; and
- when feasible collect data to understand the sustainability of outcomes.
Read more
Participants will:
- 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.
Read the detailed description
SCI participants who previously had an epidural stimulation device and completed the initial study can continue using stimulation programs at home once they have proven to study staff that they can use the programs and device on their own. This follow-up study will give insight into potential benefits from long-term use of spinal stimulation.
In-person follow-up visits (approx. 2 hours long) will be requested at 6-months, 1 year, and once a year until the device is removed or approved for commercial use. If the participant can't come to Kessler for an in-person visit, a remote tele-health visit will be arranged. Visits include:
- medical history since the last visit will be collected
- a physical exam
- assessments completed during the study previously enrolled in including:
- Testing of muscle and limb responses to stimulation
- Assessment of sitting, standing, and stepping function
- Bladder and bowel function tests
- Spasticity assessments
- Blood pressure monitoring
- Questionnaires
- MRI
- TMS
- DXA
- The study physician will contribute to decisions about which of these assessments are most appropriate to perform at a particular visit
- The investigators will review stimulation logs
- The investigator will review results of the assessments and discuss continuing in the follow up study.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Epidural Stimulation Programs
- Keywords
- spinal stimulation, epidural
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Stimulation ProgramsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Epidural Stimulation Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 hours prior to visit, completed 6 months, 1 year, and yearly
Secondary outcomes (3)
Questionnaires
All participants, regardless of prior training group will complete a series of questionnaires about their overall functioning at each follow-up visit. The questionnaires cover general topics about quality of life including perceived quality of life, experiences using the home stimulation program, and sexual (male or female), bladder and bowel function. These are multiple choice questions, with each answer valued between 0 and 5 points for all except the quality of life section, where answer scores vary based on question and has an overall score of 0-100.
An aggregate score for each domain will be compiled and compared with recorded scores from before, during, and directly after the training portion of the study they previously completed as a secondary measure of comparison to the assessment results.
Measured: On average, 30 minutes each visit completed 6 months, 1 year, and yearly
Imaging Assessments
Participants may be asked to repeat imaging assessments that were performed during their previous intervention study such as a Dual-energy X-ray absorptiometry (DXA) and/or MRI. Imaging data will be compared to prior imaging to monitor for any changes.
Measured: On Average, 15 minutes each visit completed 6 months, 1 year, and yearly
Spasticity Monitoring
Each participant is assigned an observer to accompany the research participant on their visits. The responsibility of the observer is to communicate with the research participant and monitor their well-being. The observer, the technicians, the research nurse and/or the research physical therapist will monitor the research participant at each visit for spasticity events. If a participant experiences a spasticity event during any training, a member of the study team will visually monitor the spasm and record the duration, location, and level of pain the participant is experiencing.
Measured: Each visit completed 6 months, 1 year, and yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start13 Jan 2025
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Forrest, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042815
- Sponsor's protocol ID
- R-1273-24
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Site Long-term Follow-up for Those With Experimental Epidural Stimulation After Severe Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07042815
- Acronym / sponsor ID
- R-1273-24
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- spinal stimulation, epidural
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life
- provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel
- collect long-term safety data; and
- when feasible collect data to understand the sustainability of outcomes.
Participants will:
- 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.
Detailed description
SCI participants who previously had an epidural stimulation device and completed the initial study can continue using stimulation programs at home once they have proven to study staff that they can use the programs and device on their own. This follow-up study will give insight into potential benefits from long-term use of spinal stimulation.
In-person follow-up visits (approx. 2 hours long) will be requested at 6-months, 1 year, and once a year until the device is removed or approved for commercial use. If the participant can't come to Kessler for an in-person visit, a remote tele-health visit will be arranged. Visits include:
- medical history since the last visit will be collected
- a physical exam
- assessments completed during the study previously enrolled in including:
- Testing of muscle and limb responses to stimulation
- Assessment of sitting, standing, and stepping function
- Bladder and bowel function tests
- Spasticity assessments
- Blood pressure monitoring
- Questionnaires
- MRI
- TMS
- DXA
- The study physician will contribute to decisions about which of these assessments are most appropriate to perform at a particular visit
- The investigators will review stimulation logs
- The investigator will review results of the assessments and discuss continuing in the follow up study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home Use and Follow-Up Visit Group | Experimental | Device: Epidural Stimulation ProgramsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Stimulation ProgramsEpidural 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. | Device | Home Use and Follow-Up Visit Group |
Primary outcome
Motor Control Assessments with stimulation
Time frame: On 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 Assessment
Time frame: on 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 Assessment
Time frame: 24 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.
3 secondary outcomes
Questionnaires
Time frame: On average, 30 minutes each visit completed 6 months, 1 year, and yearly
Imaging Assessments
Time frame: On Average, 15 minutes each visit completed 6 months, 1 year, and yearly
Spasticity Monitoring
Time frame: Each visit completed 6 months, 1 year, and yearly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Stimulation Programs in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Control Assessments with stimulation (time frame: On average, 1 hour each visit completed 6 months, 1 year, and yearly). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.