Spinal Cord InjuriesMC-PP-3NCT04879862
Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
A study testing Epidural stimulation + Stand Training, Epidural stimulation + Step Training and Epidural stimulation + Bladder Capacity Training in people with Spinal Cord Injuries, run by Claudia Angeli at 1 site in United States.
Trial summary
The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Epidural stimulation + Stand Training, Epidural stimulation + Step Training and Epidural stimulation + Bladder Capacity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 28 Apr 2029
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- non-progressive SCI
- stable medical condition
- Inability to stand and step independently
- unable to voluntarily move all individual joints of the legs
- no current anti-spasticity medication regimen
Show all 10Show fewer
- must not have received botox injections in the prior six months
- Bladder dysfunction as a result of SCI
- SCI between T1 and T10
- no greater than 1 year post injury
Who cannot join
- ventilator dependent
- untreated painful musculoskeletal dysfunction, fracture or pressure sore
- untreated psychiatric disorder or ongoing drug abuse
- cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
- pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation - Center for Spinal Stimulation
West Orange, New Jersey, 07052
Leighann Martinez, 973-324-3557, lmartinez@kesslerfoundation.org
Claudia Angeli, PhD
About this study
Official title: Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.
Read the detailed description
While the investigators have demonstrated the benefits of scES in chronic SCI with one of the largest series (23 patients to date) the investigators are acutely aware of persistent gaps that need to be filled in order to advance the field of neuromodulation forward. Technological advances to upgrade the stimulator's programming and wireless communication platforms are critically needed in order to integrate multiple training paradigms across multiple systems (i.e. motor and autonomic), as well as take advantage of wireless monitoring technology that could improve the patient experience. The extensive patient self-monitoring, for example regular monitoring of blood pressure during bladder filling cycles, and required manual interaction with the programming device to change parameters for optimal stimulation, remains one of the largest limiting factors in the effective utilization of this technology outside of the laboratory. Without technology components developed specifically for individuals with SCI, treatment effects could be lost due to the burden placed on the individual. Our aim is to develop technology that will interact with currently available systems, to facilitate the implementation and integration of training paradigms for the recovery of locomotion and bladder function in individuals with acute SCI and promote safe long-term use of the technology in the home and community. To this end, this study will provide a flexible communication platform specific for SCI, allow for the evaluation of integrated technology in individuals with high plasticity potential (< 1 year post injury) and allow for the longitudinal evaluation of therapeutic benefits of scES as individuals transition from acute to chronic phase of injury.
Aim 1: To evaluate the use of position based sensors internal to the neurostimulator to modulate stimulation parameters used in the training for motor function recovery following severe SCI.
Aim 2: To identify the scES parameters, using physiological feedback (continuous measures of systolic and diastolic pressure and heart rate), that improve bladder storage and emptying while controlling blood pressure following severe SCI.
Aim 3: To improve device technologies and develop predictive learning algorithms that will allow for the integration of multiple training paradigms used by a single participant.
- Conditions
- Spinal Cord Injuries
- Being tested
- Epidural stimulation + Stand Training, Epidural stimulation + Step Training, Epidural stimulation + Bladder Capacity Training, Epidural stimulation + Bladder Voiding Efficiency Training
- Keywords
- locomotion, epidural stimulation, bladder function
- 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 + Stand TrainingCombination product
Participants may use a standing apparatus or a less assistive device such as walker or cane. In case of upper limbs and trunk control insufficient for safely using the standing apparatus, participants will be placed on the treadmill, and a body weight support system. In this case, the level of body weight support will be continuously reduced as the individuals increase their ability to bear weight. A trainer positioned behind the participant will aid in pelvis and trunk stabilization. Trainer(s) positioned at the lower limb will provide manual facilitation for knee extension during standing. Manual facilitation at the trunk-pelvis and at the legs will be used only when needed.Participants will be encouraged to stand for as long as possible throughout the training session, with the goal to stand for 60 minutes with the least amount of assistance.
Epidural stimulation + Step TrainingCombination product
Participants may be placed on the treadmill in an upright position and suspended in a harness. All trainers are careful to provide manual assistance only when needed. A trainer positioned behind the research participant will aid in pelvis and trunk stabilization, as well as appropriate weight shifting and hip rotation during the step cycle. Trainers positioned at each limb will provide manual assistance to promote knee extension and knee flexion and toe clearance. Research participants will step at various body weight load and speed. Research participants will take a break and rest at any time they feel the need to during the session. If independence is achieved during stepping, some training might be performed overground with appropriate assistive device and manual assistance to maintain participant safety. Participants will be encouraged to step for 60 minutes with the least amount of assistance. Seated or standing resting periods will occur when requested by the individuals
Epidural stimulation + Bladder Capacity TrainingCombination product
We will initially conduct daily training for capacity in a supervised on-site lab setting. Optimal configurations will be used. The storage phase configuration will be used until the time for voiding/catheterization. The training procedure will be repeated for up to 8 hours daily on-site until three consecutive stable days of maintaining a consistent capacity values are achieved and deemed safe. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation (urodynamics and questionnaires). On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home-based training for bladder capacity.
Epidural stimulation + Bladder Voiding Efficiency TrainingCombination product
We will conduct training for voiding efficiency in a supervised on-site lab setting while the participant continues his/her training for capacity. Voiding without catheterization will be attempted. The training procedure will be repeated for up to 8 hours on-site until three stable days of maintaining a consistent voiding efficiency are achieved and deemed safe. The participant will be sent home for one day to perform the stimulation at home. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation and questionnaires. On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home program integrating bladder training for capacity and voiding
| Study group | Role | What they receive |
|---|---|---|
| Locomotion | Experimental | Participants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours. Receives: Combination Product: Epidural stimulation + Stand Training; Combination Product: Epidural stimulation + Step Training |
| Bladder+Locomotion | Experimental | Participants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours. Receives: Combination Product: Epidural stimulation + Stand Training; Combination Product: Epidural stimulation + Step Training; Combination Product: Epidural stimulation + Bladder Capacity Training; Combination Product: Epidural stimulation + Bladder Voiding Efficiency Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation
Ability to take independent steps
Measured: 80 sessions, approximately 3 months
Bladder storage/voiding
voiding and/or residual volume (ml)
Measured: 80 sessions, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start4 Apr 2022
- Primary completion28 May 2028 (estimated)
- Study completion28 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first 8 participants will be assigned to a group. Once technology is developed the last 8 participants will be randomized to a group.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Angeli
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Claudia Angeli, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879862
- Sponsor's protocol ID
- 17-1024 MC-PP-3
- Other IDs
- 1UH3NS116238
- Acronym
- MC-PP-3
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data included in publications will be made accessible to researchers that wish to externally validate our findings in a spreadsheet format. This data will be sent via secure email in a timely manner upon request. Due to the novelty of this intervention, we may restrict the data sharing to outcomes gathered during spinal cord mapping, assessments and certain information about stimulator configuration, secure information about the implant, nor proprietary hardware/software used during training. We will utilize the SCI Common Data Elements (CDEs) developed through the collaboration of the International Spinal Cord Society, the American Spinal Injury Association and the National Institute for Neurologic Disorders and Stroke (NINDS) CDE Projects as the uniform International SCI Data Sets.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04879862
- Acronym / sponsor ID
- MC-PP-3 / 17-1024 MC-PP-3
- Conditions
- Spinal Cord Injuries
- Keywords
- locomotion, epidural stimulation, bladder function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Claudia AngeliUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- 28 Apr 2029 (estimated)
- First posted
- 10 May 2021 (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 loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.
Detailed description
While the investigators have demonstrated the benefits of scES in chronic SCI with one of the largest series (23 patients to date) the investigators are acutely aware of persistent gaps that need to be filled in order to advance the field of neuromodulation forward. Technological advances to upgrade the stimulator's programming and wireless communication platforms are critically needed in order to integrate multiple training paradigms across multiple systems (i.e. motor and autonomic), as well as take advantage of wireless monitoring technology that could improve the patient experience. The extensive patient self-monitoring, for example regular monitoring of blood pressure during bladder filling cycles, and required manual interaction with the programming device to change parameters for optimal stimulation, remains one of the largest limiting factors in the effective utilization of this technology outside of the laboratory. Without technology components developed specifically for individuals with SCI, treatment effects could be lost due to the burden placed on the individual. Our aim is to develop technology that will interact with currently available systems, to facilitate the implementation and integration of training paradigms for the recovery of locomotion and bladder function in individuals with acute SCI and promote safe long-term use of the technology in the home and community. To this end, this study will provide a flexible communication platform specific for SCI, allow for the evaluation of integrated technology in individuals with high plasticity potential (< 1 year post injury) and allow for the longitudinal evaluation of therapeutic benefits of scES as individuals transition from acute to chronic phase of injury.
Aim 1: To evaluate the use of position based sensors internal to the neurostimulator to modulate stimulation parameters used in the training for motor function recovery following severe SCI.
Aim 2: To identify the scES parameters, using physiological feedback (continuous measures of systolic and diastolic pressure and heart rate), that improve bladder storage and emptying while controlling blood pressure following severe SCI.
Aim 3: To improve device technologies and develop predictive learning algorithms that will allow for the integration of multiple training paradigms used by a single participant.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first 8 participants will be assigned to a group. Once technology is developed the last 8 participants will be randomized to a group.
| Arm | Type | Receives |
|---|---|---|
| Locomotion | Experimental | Combination Product: Epidural stimulation + Stand Training, Combination Product: Epidural stimulation + Step TrainingParticipants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours. |
| Bladder+Locomotion | Experimental | Combination Product: Epidural stimulation + Stand Training, Combination Product: Epidural stimulation + Step Training, Combination Product: Epidural stimulation + Bladder Capacity Training, Combination Product: Epidural stimulation + Bladder Voiding Efficiency TrainingParticipants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age
- non-progressive SCI
- stable medical condition
- Inability to stand and step independently
- unable to voluntarily move all individual joints of the legs
Key exclusion criteria (5 listed)
- ventilator dependent
- untreated painful musculoskeletal dysfunction, fracture or pressure sore
- untreated psychiatric disorder or ongoing drug abuse
- cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
- pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
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 + Stand TrainingParticipants may use a standing apparatus or a less assistive device such as walker or cane. In case of upper limbs and trunk control insufficient for safely using the standing apparatus, participants will be placed on the treadmill, and a body weight support system. In this case, the level of body weight support will be continuously reduced as the individuals increase their ability to bear weight. A trainer positioned behind the participant will aid in pelvis and trunk stabilization. Trainer(s) positioned at the lower limb will provide manual facilitation for knee extension during standing. Manual facilitation at the trunk-pelvis and at the legs will be used only when needed.Participants will be encouraged to stand for as long as possible throughout the training session, with the goal to stand for 60 minutes with the least amount of assistance. | Combination product | Bladder+Locomotion, Locomotion |
| Epidural stimulation + Step TrainingParticipants may be placed on the treadmill in an upright position and suspended in a harness. All trainers are careful to provide manual assistance only when needed. A trainer positioned behind the research participant will aid in pelvis and trunk stabilization, as well as appropriate weight shifting and hip rotation during the step cycle. Trainers positioned at each limb will provide manual assistance to promote knee extension and knee flexion and toe clearance. Research participants will step at various body weight load and speed. Research participants will take a break and rest at any time they feel the need to during the session. If independence is achieved during stepping, some training might be performed overground with appropriate assistive device and manual assistance to maintain participant safety. Participants will be encouraged to step for 60 minutes with the least amount of assistance. Seated or standing resting periods will occur when requested by the individuals | Combination product | Bladder+Locomotion, Locomotion |
| Epidural stimulation + Bladder Capacity TrainingWe will initially conduct daily training for capacity in a supervised on-site lab setting. Optimal configurations will be used. The storage phase configuration will be used until the time for voiding/catheterization. The training procedure will be repeated for up to 8 hours daily on-site until three consecutive stable days of maintaining a consistent capacity values are achieved and deemed safe. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation (urodynamics and questionnaires). On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home-based training for bladder capacity. | Combination product | Bladder+Locomotion |
| Epidural stimulation + Bladder Voiding Efficiency TrainingWe will conduct training for voiding efficiency in a supervised on-site lab setting while the participant continues his/her training for capacity. Voiding without catheterization will be attempted. The training procedure will be repeated for up to 8 hours on-site until three stable days of maintaining a consistent voiding efficiency are achieved and deemed safe. The participant will be sent home for one day to perform the stimulation at home. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation and questionnaires. On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home program integrating bladder training for capacity and voiding | Combination product | Bladder+Locomotion |
Primary outcome
Ambulation
Time frame: 80 sessions, approximately 3 months
Ability to take independent steps
Bladder storage/voiding
Time frame: 80 sessions, approximately 3 months
voiding and/or residual volume (ml)
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 4 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data included in publications will be made accessible to researchers that wish to externally validate our findings in a spreadsheet format. This data will be sent via secure email in a timely manner upon request. Due to the novelty of this intervention, we may restrict the data sharing to outcomes gathered during spinal cord mapping, assessments and certain information about stimulator configuration, secure information about the implant, nor proprietary hardware/software used during training. We will utilize the SCI Common Data Elements (CDEs) developed through the collaboration of the International Spinal Cord Society, the American Spinal Injury Association and the National Institute for Neurologic Disorders and Stroke (NINDS) CDE Projects as the uniform International SCI Data Sets.
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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.
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 + Stand Training, Epidural stimulation + Step Training and Epidural stimulation + Bladder Capacity Training in people with Spinal Cord Injuries, run by Claudia Angeli 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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?
Contact Leighann Martinez (973-324-3557, lmartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation (time frame: 80 sessions, approximately 3 months). The study lists 2 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 4 May 2026.