Recruiting

Observational Study

Sponsor:

Claudia Angeli

Code:

NCT04879862

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Epidural stimulation + Stand Training

Epidural stimulation + Step Training

Epidural stimulation + Bladder Capacity Training

Epidural stimulation + Bladder Voiding Efficiency Training

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT04879862

Start date

Apr 4, 2022

Status verified date

Apr, 2026

Completion date

Apr 28, 2029

Anticipated

Primary completion date

May 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 18 years of age
2. non-progressive SCI
3. stable medical condition
4. Inability to stand and step independently
5. unable to voluntarily move all individual joints of the legs
6. no current anti-spasticity medication regimen
7. must not have received botox injections in the prior six months
8. Bladder dysfunction as a result of SCI
9. SCI between T1 and T10
10. no greater than 1 year post injury

Exclusion Criteria:

1. ventilator dependent
2. untreated painful musculoskeletal dysfunction, fracture or pressure sore
3. untreated psychiatric disorder or ongoing drug abuse
4. cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
5. pregnant at the time of enrollment or planning to become pregnant during the time course of the study.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Locomotion

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.

experimental: Bladder+Locomotion

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.

Interventions

Epidural stimulation + Stand Training

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 Training

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 Training

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 Training

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

Primary outcome measure

  • Ambulation [ Time Frame: 80 sessions, approximately 3 months ]
  • Bladder storage/voiding [ Time Frame: 80 sessions, approximately 3 months ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation - Center for Spinal Stimulation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Principal Investigator:

Claudia Angeli, PhD

More Information

Sponsor

Claudia Angeli

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • locomotion
  • epidural stimulation
  • bladder function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Claudia Angeli on 2026-05-04.