Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury (MC-PP-3)

Claudia Angeli

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Combination Product: Epidural stimulation + Step Training; Combination Product: Epidural stimulation + Bladder Voiding Efficiency Training; Combination Product: Epidural stimulation + Bladder Capacity Training; Combination Product: Epidural stimulation + Stand Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04879862

1UH3NS116238 (U.S. NIH Grant/Contract)

17-1024 MC-PP-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Locomotion

Experimental group

Description:

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.

Treatment:

Combination Product: Epidural stimulation + Stand Training

Combination Product: Epidural stimulation + Step Training

Bladder+Locomotion

Experimental group

Description:

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.

Treatment:

Combination Product: Epidural stimulation + Stand Training

Combination Product: Epidural stimulation + Bladder Voiding Efficiency Training

Combination Product: Epidural stimulation + Bladder Capacity Training

Combination Product: Epidural stimulation + Step Training