Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

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

Detailed Description
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The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. 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 Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six 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.

Official Title
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Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial

Conditions
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Back Pain, Pain

Intervention / Treatment
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* Device: Algovita Spinal Cord Stimulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement be undergoing a SCS trial using Algovita® SCS system sign a valid, Institutional Review Board (IRB)-approved informed consent form. be 18 years of age or older when written informed consent is obtained Exclusion Criteria: be contraindicated for an Algovita® SCS system have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments have a life expectancy of less than 2 years be participating in another clinical study that would confound data analysis have a coexisting pain condition that might confound pain ratings have a significant psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Pulse Width (<500 μsec)<br>Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec. | Device: Algovita Spinal Cord Stimulation System<br>* The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.<br>|
| Active Comparator: High Pulse Width (>1000 μsec)<br>Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec | Device: Algovita Spinal Cord Stimulation System<br>* The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Pulse Widths on Pain Clinical Outcomes | To evaluate the effect of conventional pulse widths <500 μsec and pulse widths >1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps. | For 7 days following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Targeted Pain | To evaluate the effect of conventional pulse widths <500μsecand pulse widths and >1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period. | For 7 days following intervention | 
| Distribution of Paesthesia | At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. | For 7 days following intervention | 
| Research Participant Program Preference | At the end of the trial period, subjects will be asked to select their favorite program. | For 7 days following intervention | 
| Quality of Pain Relief | At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor | For 7 days following intervention | 
| Research Participant Pain Relief Satisfaction | At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied | For 7 days following intervention | 
| ≥ 50% Pain Relief | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm) | For 7 days following intervention | 
| Rate of AEs | Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit. | For 7 days following intervention |