Clinical trial NCT03526055: Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial
Official title: Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Stimulation
Pain, Back
Pain
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject Pain Relief
timeFrame: up to 8 days
Secondary outcomes:
measure: Distribution of Paresthesia
timeFrame: Up to 8 days
measure: Subject Preference
timeFrame: Up to 8 days
measure: Quality of Pain Relief
timeFrame: Up to 8 days
measure: Subject Satisfaction
timeFrame: Up to 8 days
measure: Achievement of ≥50% Pain Relief
timeFrame: Up to 8 days
measure: Rate of AEs
timeFrame: From spinal cord stimulation implant through study completion or study exit, Up to 8 days
Other outcomes:
Locations:
city: Centerville
country: United States
facility: Ohio Pain Clinic
state: Ohio
Study officials:
affiliation: Ohio Pain Clinic
name: Amol Soin, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
citation: North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, Rybock JD, Long DM. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery. 1991 May;28(5):685-90; discussion 690-1.
citation: Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
citation: Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63. doi: 10.3171/jns.1978.48.2.0259.
citation: Lehmann TR, LaRocca HS. Repeat lumbar surgery. A review of patients with failure from previous lumbar surgery treated by spinal canal exploration and lumbar spinal fusion. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):615-9.
citation: Jobling DT, Tallis RC, Sedgwick EM, Illis LS. Electronic aspects of spinal-cord stimulation in multiple sclerosis. Med Biol Eng Comput. 1980 Jan;18(1):48-56. doi: 10.1007/BF02442479. No abstract available.
citation: Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. doi: 10.1159/000102196.
citation: Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997 May;40(5):990-6; discussions 996-9. doi: 10.1097/0006123-199705000-00023.
citation: Gould B, Bradley K. Pulse width programming in spinal cord stimulators. Abstract of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22-25. San Diego, CA
citation: Yearwood TL, Hershey B, Bradley K, Lee D. Pulse width programming in spinal cord stimulation: a clinical study. Pain Physician. 2010 Jul-Aug;13(4):321-35.
citation: Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.
citation: Grill WM Jr, Mortimer JT. The effect of stimulus pulse duration on selectivity of neural stimulation. IEEE Trans Biomed Eng. 1996 Feb;43(2):161-6. doi: 10.1109/10.481985.