Task-specific Epidural Stimulation Study

Spinal Cord Injuries Clinical Trial

— TSEPI  

Official title:

Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03364660
• Other study ID #: 16.0179 TS EPI
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: University of Louisville
• Contact: Susan J Harkema, PhD
• Phone: 502-582-7443
• Email: susan.harkema[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.

Description:

Experimental Design

The investigators will enroll, implant and complete the interventions in 36 research participants who have sustained a SCI in the proposed experiments. The investigators anticipate they will need to screen 108 potential research participants to enroll 36 individuals who will complete the study. This sample size will provide sufficient replication per study group (n=4) from which variance and effect size estimates for each study hypothesis can be calculated, and hypothesis tests conducted. The investigators will also select individuals to assure that there are a minimum of 25% (n=9) women to adequately represent the percentage in the SCI population. The investigators will study each cohort of patients comprehensively, and each individual will be allocated to the group interventions based on the method of minimization. Research participants will be randomized into group interventions. This novel approach of conducting repeated experiments with comprehensive assessments in a smaller cohort of patients, rather than a more traditional approach of including a large number of patients and focusing on a single outcome, will advance both clinical and scientific knowledge in this highly complex population. The investigators have found success with the smaller cohort approach because they can employ more rigorous, quantitative and sensitive outcomes that not only inform them about the potential clinical efficacy, but also provide further knowledge of the mechanisms of neural control of movement and other physiological mechanisms related to cardiovascular, respiratory, bladder, bowel and sexual function.

Group A:

• Vol-scES during voluntary leg movement training while sitting or lying supine (A1).

• CV-scES during sitting or lying supine (A2).

Group B:

• Vol-scES during voluntary leg movement training + Stand-ES during stand training (B1).

• CV-ES during sitting or lying supine + Stand-ES during stand training (B2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Non-progressive spinal cord injury

• At least 2 years post injury

• Stable medical condition

• Unable to voluntarily move all individual joints of the legs

• Unable to stand independently

• Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period

• Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity

• Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

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 spinal cord injury

• Bladder botox injections less than 12 months prior to implant

• Colostomy bag, urostomy

• Any implanted pump (i.e., baclofen pump, pain pump, etc)

• Ongoing nicotine use

• 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

Device:
• Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.

Biological:
• Stand Training
Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Christopher Reeve Paralysis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments		20 months
Primary	Recovery of voluntary movement as assessed by functional movement assessments		20 months