The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Albany Medical College
Albany, New York, United States
Numeric Rating Scale
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
Time frame: 3 months
McGill Pain Questionnaire (MPQ)
Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.
Time frame: 3 month
Oswestry Disability Index (ODI)
This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
Time frame: 3 months
Pain Catastrophizing Scale (PCS)
Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.
Time frame: 3 months
Beck Depression Index (BDI)
This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63
Time frame: 3 months
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