Shepherd Center

Home

Current Research Studies (Volunteers Needed)

If you are interested in participating in a clinical trial, please contact the research coordinator listed for that particular clinical trial or complete the participation form to the right. The participation form will be forwarded to the program coordinator and you will be contacted by the appropriate person.

Clinical evaluation of mobility and seating devices, positioning supports, and horizontal support surfaces [272]

Principal Investigator: Stephen Sprigle, PhD, PT - Georgia Institue of Technology/Center for Assistive Technology & Environmental Access (CATEA)

Study Description: Manufacturers are often interested in having their products evaluated by an independent facility with experience in seating and positioning. The purpose of this study will be to periodically clinically evaluate commercial supports and pre-production prototypes to identify indications and contra-indication of use. This study might help improve final designs before a support is marketed.

Contact: Email Sharon Sonenblum, PhD, or call 404-385-0633.

Muscle plasticity, fitness and health after SCI: Surface neuromuscular electrical stimulation-induced resistance exercise therapy & glucose tolerance in people with complete SCI with impaired glucose tolerance or Type II diabetes [367]

Principal Investigator: Kevin McCully, PhD - University of Georgia

Study Description: The purpose of this study is to determine if exercise using electrical stimulation to the muscles in the legs will lead to improved glucose tolerance in people with complete SCI who either have diabetes or who are pre-diabetic.

To participate in this study, you must:

Be 18 – 39 years old
C6-T10
AIS A or B
Have a normal range of motion about the hip, knee and ankle joints
Have diabetes or pre-diabetes since the injury

Contact: Email Heather Guerrero, or call 404-350-7522.

Evaluation of a NeuroRecovery Network (NRN) for functional, health, and quality of life improvements after SCI [383]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The NeuroRecovery Network is a national collaboration of seven medical centers that provides an intensive clinical program of activity-based interventions to people with paralysis. Data collected from all centers enter a web-based database for analysis to optimize treatment plans. This project is funded and supported by the CDC and the Christopher and Dana Reeve Foundation.

To participate in this study, you must:

Have a motor incomplete SCI (AIS C-D)with movement in the legs
Have an SCI at T10 or above (an upper motor neuron injury)
Have completed inpatient rehabilitation
Be willing to attempt to wean off of anti-spasmodic medications
Not have had botox in the last 3 months

Contact: Email Velma Moore, RN, or call 404-350-3102.

The Spinal Cord Injury Model System (SCIMS) Program [398]

Principal Investigator: Keith Tansey, MD, PhD and Lesley Hudson, MA

Study Description: The Spinal Cord Injury Model System (SCIMS) Program is funded by the National Institute on Disability and Rehabilitation Research (NIDRR). The Shepherd Center program is called the “Southeastern Regional SCIMS Program at Shepherd Center and consists of the following: 1.) execution of the continuum of care; 2.) performance of both site specific and collaborative research; and 3.) data collection. Among the research projects being conducted during the current cycle, Shepherd Center is involved in the following: two site specific projects (conducted only at Shepherd Center), and four modular research projects (each one led by one of the current model system sites, as collaborations among several SCIMS facilities). The two site specific projects are: “Evaluation of an Improved Method to Assess and Follow the Recovery of Motor Control in SCI;” (see project 468) and “A Longitudinal Study of Gainful Employment 10 Years After SCI Onset: Comparisons of Those Who Do and Do Not Return to the Pre-Injury Employer.” The four modular, collaborative projects are: “Longitudinal Follow-Up of Individuals Having Diaphragm Pacing Systems Implanted;” Evaluating the Sensitivity and Responsiveness of the SCI-QOL CATs;” “Extending the SCIRehab Project—Five Year Follow-Up;” and “Neurological Recovery Project.”

Contact: Email Pat Duncan, BS, or call 404-350-7591.

Rehabilitation Engineering Research Center for Wireless Technologies - Facilitating user centered research: The Consumer Advisory Network [410]

Principal Investigator: Mike Jones, PhD

Study Description: The cornerstone of this project is an ongoing nationwide Survey of User Needs (SUN) on use and usability of wireless communications technology by people with disabilities. The results are used to educate the wireless industry and the general public in order to promote usability of accessible wireless devices and services for people of all ages and abilities. Additionally, we invite respondents to join our Consumer Advisory Network (CAN) whose members are periodically asked to participate in subsequent surveys, focus groups, and user testing of wireless technology.

To participate in this study, you must:

Be 18 years of age or older
people with any type of disability
any degree of impairment (from minimal to considerable)

To complete our Survey of User Needs and join our Consumer Advisory Network online, please visit: http://wirelessrerc.org/for-consumers/survey-of-user-needs.html

To take the survey over the telephone or for more information, please contact John Morris.

Contact: Email John Morris, PhD, or call 404-367-1348.

The effect of combined resistance and plyometric training on locomotor recovery following incomplete SCI [455]

Principal Investigator: Mike Jones, PhD

Study Description: The purpose of this study is to determine if a protocol of intensive strengthening of lower extremity muscles impaired by a spinal cord injury (SCI) along with plyometric training will improve the quality and speed of walking for those individuals who have sustained a motor incomplete SCI. Participants in this study will complete three exercise sessions per week for a 12 week period of intensive strengthening and plyometric training. The quality and speed of over ground gait will be assessed prior to and after completion of the 12 week protocol for each participant.

To participate in this study, you must:

Between 18-39 years of age
Incomplete cervical (C1-C8) SCI more than 1 year ago
Able to walk 50 feet with only one person assist and/or assistive device
Demonstrate self-selected gait speed during 10m walk test less than 0.8m/s

Contact: Email Nicholas Evans,MHSc, ACSM HFS, or call 404-590-9565.

The use of wheelchairs, wheelchair cushions and other mobility assistive devices in everyday life [463]

Principal Investigator: Stephen Sprigle, PhD, PT - Georgia Institue of Technology/Center for Assistive Technology & Environmental Access (CATEA)

Study Description: Understanding how wheelchairs and cushions are used is important for many reasons. Prescriptions can be improved, designs can reflect actual use and policy can be written to reflect use. This project will place sensors on your wheelchair and/or cushion for one week to monitor use.

To participate in this study, you must:

Be 18 or older
Use a wheelchair or other mobility assistive device.

Contact: Email Chris Maurer, MPT, ATP or call 404-367-1333.

The Brain Motor Control Assay (BMCA) - Using Standard Electromyographic Techniques to Test Supraspinal Control of Spinal Cord Function in Spinal Cord Injury [468]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The Brain Motor Control Assessment (BMCA) is a set of tests designed to determine how much control the brain has over the spinal cord following spinal cord injury (SCI). This is done by measuring the electrical activity in muscles during specific testing procedures. These recordings may also help us design more specific treatment plans for different patients. This study is part of the Model Systems Grant for 2011-2016.

To participate in this study, you must:

Be age 18-59 years old
Either have an intact neurological system; or have a spinal cord injury and have been discharged from ICU
Have any ASIA Impairment Scale (A, B, C, D, or E)

Contact: Email Joy Bruce, MSPT, PhD, NCS, or call 404-603-4611.

The Brain Motor Control Assessment (BMCA) – evaluating supraspinal control of spinal cord function in spinal cord injury during standing and testing in the Lokomat® [483]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The Brain Motor Control Assessment (BMCA) is a set of tests designed to determine how much control the brain has over the spinal cord following spinal cord injury (SCI). This is done by measuring the electrical activity in muscles during specific testing procedures. The recordings for this study will be taken while the participant is either standing or walking in the Lokomat®. Using these recordings gives us a more refined assessment of how the brain can control spinal cord function after SCI and may help us design more specific treatment plans for different patients.

To participate in this study, you must:

Be 18-59 years old
Either have an intact neurological system; or have a spinal cord injury and have been discharged from ICU
If you have a spinal cord injury, level of injury is between C4 and S1:
If C4, ASIA Impairment Scale C or D
If C5 or below, any ASIA Impairment Scale (A, B, C, D, or E)

Contact: Email Joy Bruce, MSPT, PhD, NCS or call 404-603-4611.

Measurement of Simultaneous H-Reflexes in Multiple Lower Extremity Muscles of Subjects With or Without SCI During Rest and Stepping in the Lokomat ® [488]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: This study will examine reflexes simultaneously in multiple muscles of the lower extremities of subjects with or without spinal cord injury (SCI). These reflexes will result from electrical stimulation of the spinal nerve roots in the low back while a subject is lying down and then while he is standing or stepping in the robotic gait orthosis called the Lokomat®. The reflexes will be recorded with standard electromyography (EMG) electrodes over multiple leg muscles. We will analyze these reflexes in order to understand how positional changes affect motor function in patients with SCI compared to subjects without SCI. This study will serve as a foundation for additional studies examining the effects of locomotor training on lower extremity function in persons with spinal cord injury.

To participate in this study, you must:

Age 18-59 years old
Either have an intact neurological system or have a spinal cord injury
If you have a spinal cord injury, level of injury is between C4 and T10:
If C4, ASIA Impairment Scale C or D
If C5 or below, any ASIA Impairment Scale (A, B, C, D, or E)
Have time since injury be between 3 months and 5 years

Contact: Email Joy Bruce, MSPT, PhD, NCS, or call 404-603-4611

Comparison of pressure relief behaviors between persons with and without recurrent pressure ulcers [494]

Principal Investigator: Sharon Sonenblum, PhD - Georgia Institute of Technology

Study Description: The purpose of the study is to measure the relationship between pressure ulcer history and real-world pressure relief (PR) behaviors (weight shifts) in persons with SCI. Participants will sit on a pressure mat and spend 1-2 weeks with the PR monitor attached to their wheelchair cushion. During this time it will record information on your pressure relief behaviors. Researchers will compare pressure relief behaviors in people with and without a history of recurrent pressure ulcers.

To participate in this study, you must:

Be 18 + years of age
Have time since injury be more than 5 years
Use a wheelchair as main mobility device
Able to perform independent pressure reliefs.

Contact: Email Chris Maurer, PT or call 404-367-1333.

i-Step Long-Leg Orthosis: Study Protocol 1 (Orthosis Validation) [510]

Principal Investigator: Michael Goldfarb, PhD, Vanderbilt University; Co-Investigator: David Apple, MD

Study Description: This study will test the performance of a robotic exoskeleton that allows a person with paraplegia or stroke the ability to walk on all surfaces. The device also provides electrical stimulation for up to six muscles in each leg. The study is currently enrolling persons with complete paraplegia T7-T12 (those who respond to E-stim preferred) and persons with stroke who require assistance to walk.

To participate, you must:

Have complete paraplegia (a SCI, ASIA A, T7-T12) or had a stroke.
Weigh less than 220 lbs.
Have normal joint range of motion.
Not get dizzy or lightheaded when upright.

Contact: Email Clare Hartigan, MPT, or call 404-603-4619.

Examining spasticity in spinal cord injury using an experimental version of L-Stiff ® [522]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The purpose of this study is to use a research version of the Lokomat’s assessment tool, L-Stiff, to measure spasticity at the hip and knee joints in people with spinal cord injury and. The resistance to moving each joint is recorded by the Lokomat, and the muscle activity will be recorded using electromyography (EMG) on the legs. These results will be compared to results found with current clinical tests of spasticity.

To participate in this study, you must:

Be 18-59 years of age
Have an SCI AIS A, B, C, D, or E or have no SCI
Have an SCI level between C4-T10

Contact: Email Leslie VanHiel, DScPT or call 404-350-7681.

The effects of intermittent hypoxia on upper limb function in human spinal cord injury [524]

Principal Investigator: Randy Trumbower, PT, PhD - Emory University

Study Description: The purpose of this study is to determine whether breathing air with low levels of oxygen for brief periods (termed intermittent hypoxia) will improve hand function after spinal cord injury. Improvements in hand function may show the ability of the nervous system to strengthen neural pathways based on new experiences. To test this possibility, this investigation will determine if mild intermittent hypoxia exposure results in long-lasting improvement in hand strength and grasping in persons with incomplete spinal injury.

To participate in this study, you must:

Have a motor-incomplete (AIS C or D) SCI
Have an SCI level at C6-C7
Be 18-65 years of age
Not have had physical therapy for a at least 8 weeks

Contact: Email Randy Trumbower, PT, PhD, or call 404-727-3065.

Obesity/Overweight in Persons with Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention [525]

Principal Investigator: Mark Nash, PhD - The Miami Project to Cure Paralysis

Study Description: The purpose of this study is to determine whether exercise alone, or the combination of exercise and diet with professional support, will reduce body weight and decrease the risk of developing diabetes. Participants will either perform a supervised exercise program for 6 months, or will both participate in a supervised 6-month exercise program and receive nutritional counseling and professional support.

To participate in this study, you must:

Age 18 to 65 years old
Have a spinal cord injury between C5-L1 with AIS A, B, or C
SCI more than 1 year post injury
BMI ≥ 22 kg/m²

Contact: Email Kathy Kreger or call 404-350-7397.

Pilot Study – Health and Fitness Benefits of Home Exercise Program using Upper Extremity Circuit Resistance Training [526]

Principal Investigator: Elizabeth Sasso, PT

Study Description: The purpose of this study is to investigate the health and fitness benefits of a home-based design for an arm circuit resistance training (CRT) program. This exercise program was designed to provide people with spinal cord injury (SCI) an affordable, accessible, and effective means to exercise. Cardiovascular endurace, arm strength, body weight, percent body fat, presence of shoulder pain, and blood glucose and cholesterol levels will be evaluated.

To participate in this study, you must:

Be 18-65 years old
Have a traumatic spinal cord injury between T4-L1 with AIS A or B
SCI more than 1 year post
Be willing to build (or have built) a CRT set-up in your home according to set guidelines

Contact: Email Elizabeth Sasso, PT, or call 404-350-7551.

A Comparison of Robotic Body Weight Supported Locomotor Training and Aquatic Therapy for Individuals with Chronic Motor Incomplete Spinal Cord Injury [532]

Principal Investigator: Peter Gorman, MD – Kernan Orthopaedic and Rehabilitation Institute; Co-Investigator: Keith Tansey, MD, PhD

Study Description: The goal of this research is to understand the effects of aquatic therapy and robotically-assisted locomotor training on the Lokomat on walking ability and cardiovascular fitness in individuals with chronic, motor incomplete spinal cord injury. Each participant will receive one of these 2 therapies 3 times/week for 3 months and then switch to receive the other therapy 3 times/week for 3 months. Participants must commit 7 months to this study.

To participate in this study, you must:

Have a motor incomplete spinal cord injury (AIS C or D)
Age 18-65 years
Level of injury C4-T12, based on ASIA exam, with no lower motor neuron injury involvement
Spinal cord injury longer than 12 months
Completion of all conventional inpatient rehabilitation therapy

Contact: Email Leslie VanHiel, DScPT, or call 404-350-7681.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury ASUBIO#ASBI-603 [558]

Principal Investigators: Keith Tansey, MD, PhD; Ismari Clesson, RN

Study Description: This study will evaluate the safety and effectiveness of a study drug versus placebo in early Spinal Cord Injury. Participants must be enrolled at participating trauma center within 12 hours of injury and choose to transfer to Shepherd Center to complete study participation.

To participate in this study, you must:

Have a complete C4-C7 spinal cord injury (cervical)
Have a traumatic SCI occurring within 12 hours of the first dosing
Be male or female between the ages of 18 to 80 years

Contact: Email Michelle Tidwell, RN or call 404-367-1317.

Evaluation of Muscle Metabolism in Spinal Cord Injury with Near-Infrared Spectroscopy [551]

Principal Investigator: Kevin McCully, PhD; University of Georgia

Study Description: The study aims to measure muscle metabolism using magnetic resonance spectroscopy and near-infrared spectroscopy. This study will determine if this technology will make it easier and cheaper to understand changes that occur in muscle after spinal cord injury.

To participate in this study, you must:

Be 18-60 years of age
Have a SCI at a level of injury between C4-T12 OR not have any neurological diagnosis.

Contact: Email Melissa Erickson; or call 706-542-3258.

Optimizing Electrical Sensory Stimulation to Generate a Walking Pattern in Spinal Cord Injured Humans [583]

Principal Investigators: Jason White, MEE, PhD Candidate; Keith Tansey, MD, PhD

Study Description: This study will explore electrical stimulation of nerves in the legs of people with and without spinal cord injury (SCI) during walking. While subjects walk in the robotic Lokomat, we will record muscle forces and activity during different stimulation patterns. Those stimulation patterns will be changed during the walking using a computer program to try to coordinate the muscles and reduce the need for the robot. This research will lead to a better understanding of how stimulation can help improve walking in patients with SCI.

To participate in this study, you must: