Clinical trial NCT04123847: Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation
Official title: Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: epidural stimulation
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2019-10-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
Secondary outcomes:
measure: Change from baseline in resting metabolic rate after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in bladder capacity after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in bladder voiding efficiency after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in detrusor pressures during filling after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in bladder compliance after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in mean resting anal pressure after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in mean squeeze pressure after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in squeeze anal canal length after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change from baseline in bowel sensation after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
measure: Change in baseline in sexual function after 160 sessions (1 year)
timeFrame: Baseline, 160 sessions (1 year)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Susan Harkema, PhD
role: PRINCIPAL_INVESTIGATOR
References: