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

Amol Soin

Status: Completed

Conditions: Pain, Back; Spinal Cord Stimulation; Pain

Treatments: Device: Algovita Spinal Cord Stimulation System

Study type: Interventional

Funder types: Other

Identifiers

NCT03526055

Long Pulse

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

<500 µS Pulse Width

Active Comparator group

Description:

Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

Treatment:

Device: Algovita Spinal Cord Stimulation System

>1000 µS Pulse Width

Experimental group

Description:

Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

Treatment:

Device: Algovita Spinal Cord Stimulation System