Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

• Sponsor: Susan Harkema (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04123847
• Collaborator: The Leona M. and Harry B. Helmsley Charitable Trust (Other)
• Enrollment: 16
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Other: Standing and Stepping; Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
• Actual Study Start Date: Nov 2, 2020
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Stand, Step and Voluntary Training

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.; Other Names: Stand-scES Step-scES Vol-scES

Outcome Measures

Primary Outcome Measures

1. Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year) [Baseline, 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

2. Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year) [Baseline, 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

3. Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year) [Baseline, 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

Secondary Outcome Measures

1. Change from baseline in resting metabolic rate after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Resting metabolic rate

2. Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Respiratory Motor Control Assessment

3. Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Respiratory Motor Control Assessment

4. Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Respiratory Motor Control Assessment

5. Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Respiratory Motor Control Assessment (RMCA)

6. Change from baseline in bladder capacity after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Using urodynamics we will measure bladder capacity in mL.

7. Change from baseline in bladder voiding efficiency after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.

8. Change from baseline in detrusor pressures during filling after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Using urodynamics we will measure detrusor pressure in cmH2O.

9. Change from baseline in bladder compliance after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

   Using urodynamics we will measure bladder compliance in mL/cmH2O.

10. Change from baseline in mean resting anal pressure after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    Using anorectal manometry we will measure mean resting pressure in mmHg.

11. Change from baseline in mean squeeze pressure after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    Using anorectal manometry we will measure mean squeeze pressure in mmHg.

12. Change from baseline in mean squeeze increase pressure after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    Using anorectal manometry we will measure mean squeeze increase pressure in mmHg.

13. Change from baseline in squeeze anal canal length after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    Using anorectal manometry will measure squeeze anal canal length in cm.

14. Change from baseline in bowel sensation after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    Using anorectal manometry we will measure bowel sensation in mL.

15. Change in baseline in sexual function after 160 sessions (1 year) [Baseline, 160 sessions (1 year)]

    We will measure change in sexual health function using a questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• Susan Harkema
• The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

• Principal Investigator: Susan Harkema, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan Harkema, Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT04123847
• Other Study ID Numbers: 17.1024 MC-PP-2
• First Posted: Oct 11, 2019
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Susan Harkema, Professor, University of Louisville: epidural stimulation
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Jul 20, 2021