Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Kettering Health Network

Status: Completed

Conditions: Back Pain; Pain

Treatments: Device: Algovita Spinal Cord Stimulation System

Study type: Interventional

Funder types: Other

Identifiers

NCT03756012

Expanded Long Pulse

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Low Pulse Width (<500 μsec)

Active Comparator group

Description:

Spinal Cord Stimulation System will be programmed to pulse widths \<500 μsec.

Treatment:

Device: Algovita Spinal Cord Stimulation System

High Pulse Width (>1000 μsec)

Active Comparator group

Description:

Spinal Cord Stimulation System will be programmed to pulse widths \>1000 μsec

Treatment:

Device: Algovita Spinal Cord Stimulation System