Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

Spinal Cord Injuries Clinical Trial

Official title:

Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04123847
• Other study ID #: 17.1024 MC-PP-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• Standing and Stepping
Participants will have at least 80 sessions of stand and step training with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill.

Device:
• Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation
Participants will be have at least 80 sessions of stand and step training with epidural stimulation, with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill. Voluntary movement with epidural stimulation will be completed in the supine or seated position.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Susan Harkema PhD	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)	We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout	Baseline, 160 sessions (1 year)
Primary	Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)	We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout	Baseline, 160 sessions (1 year)
Primary	Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)	We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1-minute period	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in resting metabolic rate after 160 sessions (1 year)	Resting metabolic rate	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Secondary	Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)	Respiratory Motor Control Assessment (RMCA)	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in bladder capacity after 160 sessions (1 year)	Using urodynamics we will measure bladder capacity in mL.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in bladder voiding efficiency after 160 sessions (1 year)	Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in detrusor pressures during filling after 160 sessions (1 year)	Using urodynamics we will measure detrusor pressure in cmH2O.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in bladder compliance after 160 sessions (1 year)	Using urodynamics we will measure bladder compliance in mL/cmH2O.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in mean resting anal pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean resting pressure in mmHg.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in mean squeeze pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean squeeze pressure in mmHg.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean squeeze increase pressure in mmHg.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in squeeze anal canal length after 160 sessions (1 year)	Using anorectal manometry will measure squeeze anal canal length in cm.	Baseline, 160 sessions (1 year)
Secondary	Change from baseline in bowel sensation after 160 sessions (1 year)	Using anorectal manometry we will measure bowel sensation in mL.	Baseline, 160 sessions (1 year)
Secondary	Change in baseline in sexual function after 160 sessions (1 year)	We will measure change in sexual health function using a questionnaire.	Baseline, 160 sessions (1 year)