Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial

The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on clinical outcomes during a temporary SCS trial.

The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days.

The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

Inclusion Criteria:

• Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
• Study candidate is undergoing a SCS trial using Nuvectra Algostim system
• Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
• Subject is 18 years of age or older when written informed consent is obtained

Exclusion Criteria:

• Subject is contraindicated for an Algovita SCS system
• Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
• Subject has a life expectancy of less than 2 years
• Subject is participating in another clinical study that would confound data analysis
• Subject has a coexisting pain condition that might confound pain ratings
• Subject has a significant psychiatric disorder