Task-specific Epidural Stimulation Study
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | November 8, 2017 |
| End Date: | June 30, 2023 |
| Contact: | Susan J Harkema, PhD |
| Email: | TaylorBlades@KentuckyOneHealth.org |
| Phone: | 502-581-8675 |
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
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.
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.
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).
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).
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
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