Research at the Regional Spinal Cord Injury Center of the Delaware Valley

Research of the RSCICDV General Research Overview Model Systems Approach Discovering Promising Options Through Research Current Research Activites Validation Studies General Overview of Clinical Research Clinical Research Overview Clinical Trial Process Phases of Clinical Trials Inclusion and Exclusion Criteria Choosing to Participate Questions to Ask Before Participating Informed Consent Clinical Research Studies Walking Index for Spinal Cord Injury - WISCI Capabilities of Upper Extremities - CUE Basic Research Basic Research Overview Research Publications by Center Staff 2004 2003 2002 2001 2000 Refer a Patient To refer a patient to our center, call (215) 955-4444.

The research mission of the RSCICDV is to become the premier center for the evaluation of new, innovative basic and clinical science interventions that will improve the quality of life for all people with spinal cord injury. In keeping with our mission, we have dedicated ourselves to maintaining a continuous stream of research activities and publications. Included in these clinical research activities are:

Clinical Trials involving new drug therapies and physical retraining. The drugs under investigation could potentially decrease muscle spasms and improve bowel and bladder function. Drugs could also improve nervous system function and improve independence in self-care activities. Specialized physical re-training might also improve walking.

Outcome Studies can demonstrate improved neurological function and quality of life as a result of interventions, such as those above, and health care delivery systems (Model Systems). For a number of years, the RSCICDV has been at the forefront of developing standards used for the classification and evaluation of treatments in spinal cord injury. Developed under the leadership of the RSCICDV’s John F. Ditunno, MD, and the American Spinal Injury Association, the International Standards for Neurological Classification of Spinal Cord Injury, provides a universal language for classifying persons with spinal cord injury and serves as the primary endpoint in clinical trials to demonstrate improvements in neurological function. These Standards have been accepted by SCI clinical investigators and practitioners throughout the world.

Validation of Specific Outcome Measures such as the Walking Index for Spinal Cord Injury (WISCI). The RSCICDV has led the development of the most advanced and promising measure of walking function after spinal cord injury. This will be an extremely important method of determining if new treatments, drugs, and physical interventions improve walking function.

Several validation studies have been completed or are underway on the WISCI. Specific characteristics studied are listed below:

• Face Validity
• Concurrent Validity
• Predictive Validity
• Criterion Validity
• Response to Change
• Sensitivity

Basic Research. Several physicians have been awarded NIH career research training grants: one in clinical research training (Ralph J. Marino, MD) and two in basic science (Virginia Graziani, MD, and Anthony S. Burns, MD).

The NIH research trainees have pursued the theme related to clinical trials consistent with the mission of the center. Dr. Marino and Graziani studied upper and lower extremity recovery and its implications for clinical trials. Dr. Burns is exploring methods that use neurophysiologic endpoints to measure improvement in neurological function after spinal cord injury. Another important goal of this research is to understand better the changes that occur in nerve cells (neurons) below a SCI and how these changes affect recovery.

For the reader’s convenience, this website includes a SCI Research Glossary and a list of FAQs.