Restoring Sensation after Arm Amputation

STUDY BASICS

Are you an amputee with an amputation of one or both arms? Are you between 18 and 70? If so, you may be able to take part in a research study designed to develop new technologies that may improve prosthetic (artificial limb) control and reduce phantom limb pain. Compensation provided.

STUDY PURPOSE

Phantom limb pain is a debilitating condition in which the nerve endings at an amputation site continue to send pain signals to the brain. Phantom limb pain can make it difficult to wear a prosthesis (an artificial body part), and to return to normal activities and functioning. Some recent research has shown that electrical stimulation of the spinal cord nerves may help to restore natural sensation in people who have had an amputation. The purpose of this study is to learn more about the effects of stimulating the spinal nerves in amputees, and to specifically find out how that stimulation impacts phantom limb pain. Researchers hope that their findings will lead to the development of a device that can improve control of prosthetic limbs and help to reduce phantom limb pain in people who have had an amputation.

COULD THIS STUDY BE RIGHT FOR YOU?

• Are between 18-70 years of age
• Are amputees with an amputation of one or both arms
• At least 6 months post-amputation
• Not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

Participation involves up to 25 visits over a period of nine months. The study involves a medical procedure to temporarily place one to three stimulation electrodes in the space near the spinal cord. This medical procedure will be performed under local anesthesia, and will take approximately one to two hours. Afterwards, the electrodes will be connected to an external stimulator and a series of experiments will be performed to characterize the types of sensations generated by electrical stimulation of the spinal cord and spinal nerves, as well as to measure the effect of stimulation on phantom limb sensations and phantom limb pain. Participants will have one or two study visits for pre-surgical screening, one visit for electrode placement and testing, up to 20 visits for testing, and a final visit for electrode removal.