NCT03526055

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Amol Soin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Stimulation
• Pain, Back
• Pain

Interventions

Type	Name	Description
DEVICE	Algovita Spinal Cord Stimulation System	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.

Timeline

• Start date: 2018-02-26
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2018-05-16
• Last updated: 2019-02-21
• Results posted: 2019-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study