Abbott Proclaim 3660 Clinician Manual page 37

Subjects were implanted with the permanent Prodigy neurostimulation system, and the device
remained off during a recovery period. After the recovery period, subjects were randomized to
receive either burst stimulation or tonic stimulation. The implanted system was then activated and
programmed accordingly. Depending on randomization, a subject experienced either tonic
stimulation or burst stimulation first for a total of 12 weeks. At the week-12 visit, the subject was
then crossed over to the alternate stimulation mode for another 12 weeks. Subjects reported to
the office at 6, 12, 18, and 24 weeks after randomization and activation. After the primary
endpoint at the week-24 visit, all subjects were programmed to tonic or burst stimulation based on
what the subject and physician preferred, and they continued to attend follow-up visits every 6
months for 2 years or until the study closed, whichever occurred first.
The purpose of the clinical study was to collect the data needed to demonstrate the safety and
effectiveness of a neurostimulation system that is capable of both tonic and burst stimulation
modes.
SUNBURST™ Study Clinical Inclusion and Exclusion Criteria
Enrollment in the SUNBURST™ study was limited to subjects who met the following selection
criteria.
Inclusion Criteria
Subjects were limited to those who met all of the following criteria:
Subject signed an informed consent to participate in the study.

Subject was at least 22 years old.

Subject had chronic intractable pain of the truck and/or limbs.

Subject scored a baseline average of 60 or higher for average daily overall pain on the visual

analog scale (VAS) 7-day pain diary.
Subject tried "best" medical therapy, but failed at least three documented, medically

supervised treatments (including, but not limited to, physical therapy and acupuncture) and
failed medication treatment from at least two different classes.
Subject's pain-related medication regimen was stable 4 weeks before the screening

evaluation.
The Investigator evaluated the subject's medical record to ensure that the subject was a

good candidate for a neurostimulation system.
A psychologist or psychiatrist evaluated the subject and found him or her to be a suitable

SCS candidate.
Subject agreed not to increase the number of or dosage of pain-related medications from

activation through the week-24 follow-up visit.
Subject was willing to cooperate with the study requirements such as complying with the

treatment regimen and completing all office visits.
Subject was female candidate of childbearing potential who agreed to commit to using

effective contraception (including, but not limited to, sterilization, barrier devices, oral
contraceptives, intrauterine devices (IUDs), condoms, the rhythm method, or abstinence)
throughout the study.
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