Clinical trial for spinal cord injuries treatment begins

By Pamela Perry

The trial at the IUSM, approved by the Food and Drug Administration, will be based on treatments developed at Purdue. In these treatments, dogs suffering paralysis from natural causes regained partial function.

A major source of private funding for the universities’ joint paralysis research effort is Mari Hulman George, chairman of the Indianapolis Motor Speedway, who is contributing $2.7 million to be split evenly between Purdue and IU. The gift is being used to establish endowed professorships at both universities. Her gift will augment funding from the state, which has committed $1 million annually for two years to Indiana and Purdue.

The human clinical trial will test whether weak electrical fields applied to spinal cord injuries can promote better functional recovery through regeneration of injured spinal cord nerve fibers. The electrical fields are imposed over the spinal cord injury through use of a new implantable medical device called an extraspinal oscillating field stimulator.

The trial will begin this year and is open to patients between the ages of 18 and 65 (see box below).

“The IU-Purdue collaboration in spinal cord research is an important partnership,” said Dr. Paul Nelson, chairman of the neurosurgery division at IUSM. “It fits the universities’ drive to engage in translational research, which creates an effective bridge between basic science research and patient care.”

Spinal cord injuries represent a growing medical and financial dilemma for state governments, yet only a few other states—Kentucky, Florida and Virginia among them—fund paralysis research.

Spinal cord patient trial

Patients must be between the ages of 18 and 65 and have a complete motor-spinal cord injury below the cervical spine level 4. Eligible patients must enter the trial within 18 days of the time they are injured.

Ineligible groups: Those who have incurred multiple life-threatening injuries. Those who are medically unstable because of other diseases such as heart disease and cancer. Patients cannot be pregnant, have ankylosing spondylosis (arthritis in the spine), be ventilator dependent or have any other implanted electrical devices. Injury cannot be caused by a gunshot wound, and patients cannot have a mental illness that precludes an informed consent.

Other exclusionary criteria are available from the clinical trials coordinator, Shannon Hagy, 317-278-7990.

Research data developed through investigations at the Purdue University School of Veterinary Medicine.