Prodigy-I
Research type
Research Study
Full title
A Post-Market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs
IRAS ID
156809
Contact name
Ganesan Baranidharan
Sponsor organisation
St Jude Medical
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to confirm the long term results of the Prodigy neurostimulator system which uses Burst technology.
Patients who have been deemed suitable for the implantation of a neurostimulator system will be invited to take part in the study after gaining appropriate consent.
Neurostimulators stimulate the spinal cord using a small lead which is placed by a doctor into the epidural space (an area around the spinal cord). The lead is connected to a small device similar to a pacemaker which is implanted under the skin. The device contains the power source and electronics which produce electrical pulses.
These pulses are delivered down the lead and stimulate the nerves in the spinal cord. Traditionally the pulses cause a tingling sensation called paraesthesia which helps mask the patient's pain. This traditional version of SCS known as tonic simulation has and still works for many patients. Some patients find that the effect wears off over time and the pain increases again, others may find the paraesthesia problematic as it may increase or decrease in strength depending on their activity or position (ie: lying down or standing).
As a consequence new ways to stimulate the spinal cord have been developed. One such method is burst where bundles of pulses are delivered instead of a regular spaced single pulses. burst stimulation is also designed to be given in a way where little or no tingling is felt. Because burst employs a different electrical 'pattern' it also 'talks' to the nervous system differently. There is evidence that as well as lowering pain it can reduce the overall perception and emotional response to pain as well.
This study hopes to evaluate patients physical & emotional pain outcomes and overall satisfaction with the Prodigy device using Burst mode over 12 months.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1025
Date of REC Opinion
9 Sep 2014
REC opinion
Further Information Favourable Opinion