Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
MC-PP-3
Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
2 other identifiers
interventional
16
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2029
May 4, 2026
April 1, 2026
6.2 years
April 26, 2021
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ambulation
Ability to take independent steps
80 sessions, approximately 3 months
Bladder storage/voiding
voiding and/or residual volume (ml)
80 sessions, approximately 3 months
Study Arms (2)
Locomotion
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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
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.
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
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Foundation - Center for Spinal Stimulation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 26, 2021
First Posted
May 10, 2021
Study Start
April 4, 2022
Primary Completion (Estimated)
May 28, 2028
Study Completion (Estimated)
April 28, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Upon request
- Access Criteria
- Upon request
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.