Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04879862
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Not Provided