Chronic Pain Clinical Trial
Official title:
Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain
This is a prospective, multi-center feasibility study of effectiveness and safety of the Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
Study subjects will be identified from the pool of candidates for SCS therapy affiliated
with, or referred to, the clinical sites. Subjects will participate in this investigational
plan that includes entry criteria evaluation, Baseline assessments, trial stimulation phase,
and post-trial assessment. Subjects with a successful Trial Phase will receive a permanent
implant of an Implantable Pulse Generator (IPG) and leads, and undergo 12 months of
stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device
Activation.
Subjects who sign the informed consent will undergo evaluations to determine eligibility for
the study based on the inclusion and exclusion criteria. Baseline assessments will also
include measures for pain, disability, functioning, medication use, quality of life,
depression and sleep.
Implantation and use of the Senza System will follow the Nevro Physician's Manual and
supporting Manuals. Subjects will undergo a Trial Phase lasting up to 14 days to determine
his/her response to SCS therapy. Following the Trial Phase with external device stimulation,
subjects will be assessed for their pain, and those who have a successful Trial Phase will be
eligible to proceed to permanent implantation of a SCS system.
Following permanent device implant, the IPG will be "activated" and thus, stimulation
delivered on an ongoing basis for 12 months. At 1 month and 9 months following Post-Permanent
Device Activation, assessments of pain and adverse events will be made. At 3, 6, and 12
months Post-Permanent Device Activation, subjects will be assessed for pain and adverse
events as well as disability, functioning, medication use, quality of life, depression and
sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject
satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.
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