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Ongoing Research

Here is a list of current studies/initiatives that Shepherd Center is participating in to help increase our understanding of Spinal Cord Injuries. These studies are not recruiting volunteers at the present time.

The Impact of Cognitive Functioning on Outcomes following SCI [288]

Principle Investigator: Stephen Macciocchi, PhD, ABPP

Study Description: Involves determining the impact of co-occurring TBI on SCI rehabilitation outcomes at discharge from inpatient rehabilitation and at one-year follow-up. 60% of persons who sustain an SCI also sustain a TBI. Outcome data is currently being analyzed.

Contact: Email Stephen Macciocchi, PhD, ABPP, or call 404-350-7553.

Changes in interface pressure in variable position wheelchairs [358]

Principle Investigators: Stephen Sprigle, PhD, PT

Study Description: The purpose of this study was to determine changes in interface pressures between the subject’s body and the support surfaces of a wheelchair as it transitions into different positions. Tilt-in-space, recline and standing positions will be studied using the same wheelchair system (Levo).

Contact: Email Michelle Nemeth, PT, CCRP, or call 404-350-7661.

Predicting personal care hours for patients with SCI [369]

Principal Investigator: Shari McDowell, PT

Study Description: The purpose of the study is to determine the number of personal care hours required in the home for patients with spinal cord injury after they are discharged from inpatient rehabilitation. This study will allow the researchers to better predict the number of personal care hours that are necessary for patient care in the home and will be helpful to families and patients in planning for care.

To participate in this study, you must:

18 to 55 years of age at the time of enrollment in the study
Traumatic spinal cord injury paraplegia or tetraplegia at C5-C8 level (complete or incomplete)
Patients at Shepherd Center for initial inpatient rehabilitation AND day program
Patients discharged from Shepherd Center to home after initial inpatient rehabilitation

Contact: Email Shari McDowell, PT, or call 404-350-7619.

Outcomes of cervical immobilization vs. nonimmobilization following surgery in quadriplegia [385]

Principal Investigator: David Apple, MD

Study Description: This is a retrospective study (chart review) to determine if cervical immobilization after surgery is more effective than nonimmobilization in reducing or preventing complications. If so, what duration of time in the cervical collar is optimal? Is one surgical technique superior to another in reduction of complication rate?

To participate in this study, you must:

have medical records describing treatment for a cervical level spinal cord injury
have had a cervical fracture level
fracture classification: burst, dislocation, fracture dislocation
any ASIA classification (A, B, C, D, or E)

Contact: Email Kim Gilbert, MD.

A multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the safety and efficacy of repeat treatment with two dose levels of BOTOX® (Botulinum Toxin Type A) purified neurotoxin complex followed by a treatment with BOTOX® in patients with urinary incontinence due to neurogenic detrusor overactivity [389]

Principal Investigator: Jenelle Foote, MD

Study Description: This study involves utilizing botox to treat detrusor overactivity in neurogenic bladder. The aim is to decrease urinary leakage between intermittent catherizations and evaluate the most effective dose.

To participate in this study, you must:

Age 18 – 80
SCI patient must be T1 or below
Urinary incontinence as a result of neurogenic detrusor overactivity (as identified on urodynamics) for at least 3 months.
SCI patient must use clean intermittent catheterization for bladder mgmt

Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.

The Effects Of FES Cycle Ergometry Training To Improve Balance And Locomotion In Individuals With Incomplete SCI. [407]

Principle Investigator: Deborah Backus, PhD, PT

Study Description: The purpose of this study was to see if people with incomplete SCI (AIS C) can benefit from training on the functional electrical stimulation bike. The investigators of this study want to see if this bike can improve the strength in the legs, and improve walking in people with motor incomplete (ASIA C) spinal cord injury.

Contact: Email Deborah Backus, PhD, PT, or call 404-350-7599.

An Open-label, Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects with Neurogenic Bladder following Spinal Cord Injury [417]

Principle Investigator: Bruce Green, MD

Study Description: Shepherd Center is one of several hospitals around the US participating in a Phase II clinical trial of a bioengineered bladder called the Tengion Neo-Bladder Augment(TM). The Neo-Bladder is made from a combination of the patient's healthy cells taken from a tissue sample and grown in a Tengion laboratory. The Neo-Bladder is surgically attached to the patient's native bladder to expand its capacity. This procedure improves the patient's health by reducing the risk of urinary tract infections and kidney damage in addition to stopping urinary leakage.

Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.

Using the Spinal Cord Injury Independence Measure III (SCIM III) to measure functional outcomes in post acute rehabilitation after spinal cord injury [413]

Principal Investigator: Sarah Morrison, PT

Study Description: The purpose of this study is to analyze functional gains, as measured by the SCIM-III that occur during a post acute rehabilitation program. The sensitivity of the assessment tool as well as the floor and ceiling effects of the SCIM-III scoring will be evaluated.

Contact: Email Sarah Morrison, PT, or call 404-350-7676.

Improving transfer mobility and wheelchair propulsion using real-time feedback [423]

Principle Investigator: Chris Maurer, MPT, ATP

Study Description: This study is investigating the use of video feedback to improve rehabilitation training. Training will be supplemented using “Dartfish,” a real time video-based training software most commonly used by coaches and trainers for sports applications. Training will focus on two tasks, transfers and wheelchair propulsion.

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

Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects with Spasticity Due to Spinal Cord Injury [435]

Principle Investigator: David Apple, MD

Study Description: This study is evaluating the safety and effectiveness of a sustained release form of Baclofen, an anti-spasticity medication. Three different doses will be tested and since the trial has a “cross-over” design all patients enrolled will eventually get the medication even if they start out in the placebo group.

Contact: Email Ismari Clesson, RN, CCRP, or call 404-350-7651.

Evaluation of the pretest clinical score for the diagnosis of heparin induced thrombocytopenia (HIT) in SCI and TBI [443]

Principal Investigator: Ismari Clesson, RN

Study Description: This is a chart review study by a medical resident. The goal of this study is to assess both SCI and TBI inpatient populations for risk factors for the development of heparin induced thrombocytopenia (“HIT”). HIT is an immune-mediated adverse drug reaction to heparin resulting in a prothrombotic state. It is estimated to occur in up to 5% of patients receiving unfractionated heparin.

Contact: Email Anna Choo, MD, or call 404-520-8293.

Year 2 Follow-Up of Patients with the NeuRx RA/4 Ventilatory Assist Device [445]

Principle Investigator: Michelle Nemeth, PT

Study Description: The purpose of this study is to follow patients who participated in the “Electronic activation of the diaphragm for ventilatory assist – Neurx RA/4 ventilatory-assist, percutaneous, multi channel, neuromuscular stimulator” study for their second year post implantation.

Contact: Email Michelle Nemeth, PT, CCRP, or call 404-350-7661

AstroWheelie: Wheelchair controlled game based exercises [450]

Principal Investigator: Thad Starner, PhD

Study Description: The purpose of the project is to examine the effectiveness of rehabilitation centered gaming devices as a complement to traditional therapy methodologies. The goal is to create a stand alone product that can be used both within a home setting as well as in a rehabilitation gym. Key areas of emphasis include cost effectiveness, ease of use, and entertainment value. Development of the game requires asking manual wheelchair users to test successive iterations until the game is deemed sufficiently refined.

To participate in this study, you must: