Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

Susan Harkema PhD

Status

Active, not recruiting

Conditions

Spinal Cord Injuries

Treatments

Other: Standing and Stepping

Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04123847

17.1024 MC-PP-2

Details and patient eligibility

About

This study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with scES in humans with severe paralysis. Training will consist of practicing stepping, standing and voluntary movements in the presence of specific scES configurations designed specific for stepping (Step-scES), specific for standing (Stand-scES) and for the voluntary movements of the legs and trunk (Vol-scES). Ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

non-progressive SCI
at least 2 years post injury
stable medical condition
inability to walk independently overground
unable to voluntarily move all individual joints of the legs

Exclusion criteria

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