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

Task-specific Epidural Stimulation Study



Sponsors


Source

University of Louisville

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

Yes

Is Unapproved Device

No

Is Ppsd

No


Brief 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.

Detailed 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=6) 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).

- Stand-ES during sitting or lying supine (A3).

Group B:

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

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

- ES Stand Parameters during stand training (B3).

Overall Status

Recruiting

Start Date

2017-11-08

Completion Date

2023-06-30

Primary Completion Date

2022-11-30

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
20 months
Recovery of voluntary movement as assessed by functional movement assessments
20 months
Recovery of the ability to independently stand as assessed by standing assessments
20 months

Enrollment

36

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.

Arm Group Label

Voluntary Movement Epidural Stimulation

Cardiovascular Epidural Stimulation

Stand Epidural Stimulation

Voluntary Movement ES + Stand Training

Cardiovascular ES + Stand Training

Stand ES + Stand Training



Intervention Type

Biological

Intervention Name


Description

Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.

Arm Group Label

Voluntary Movement ES + Stand Training

Cardiovascular ES + Stand Training

Stand ES + Stand Training




Eligibility

Criteria

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

- Ongoing nicotine use

- Pregnant at the time of enrollment or planning to become pregnant during the time
course of the study

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Susan J Harkema, PhD
Principal Investigator
University of Louisville

Overall Contact

Last Name

Susan J Harkema, PhD

Phone

502-581-8675

Email



Location

Facility

Status

Contact

University of Louisville
Louisville Kentucky 40202 United States
Recruiting
Last Name: Susan Harkema, PhD
Phone: 502-581-8675
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-11-01

Lastchanged Date

2017-11-30

Firstreceived Date

2017-11-16

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Louisville

Investigator Full Name

Susan Harkema

Investigator Title

Professor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

6

Arm Group

Arm Group Label

Voluntary Movement Epidural Stimulation

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for voluntary movement.


Arm Group Label

Cardiovascular Epidural Stimulation

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.


Arm Group Label

Stand Epidural Stimulation

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for standing.


Arm Group Label

Voluntary Movement ES + Stand Training

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.


Arm Group Label

Cardiovascular ES + Stand Training

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.


Arm Group Label

Stand ES + Stand Training

Arm Group Type

Experimental

Description

Participants assigned to this group will receive epidural stimulation specific for standing and will also receive stand training.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Taylor A Blades, MS

Phone

502-587-7410

Email



Acronym

TS EPI

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

November 16, 2017

Study First Submitted Qc

November 30, 2017

Study First Posted

December 6, 2017

Last Update Submitted

November 30, 2017

Last Update Submitted Qc

November 30, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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