Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck Pain

NCT02385201 | Completed

• 1 other identifier: CA2014 US
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who respond to Senza SCS therapy (as assessed by VAS) for upper limb or neck pain

  3 months

Study Arms (1)

Senza

EXPERIMENTAL

Subjects with chronic, intractable pain of the upper limbs and/or neck will be implanted with a Senza Spinal Cord Stimulation (SCS) system designed to deliver electrical stimulation to the spinal cord.

Device: Senza

Interventions

Senza DEVICE

Spinal Cord Stimulation

Senza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain
• Considering daily activity and rest, have average upper limb and/or neck pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
• Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
• Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device
• Be 18 years of age or older at the time of enrollment
• Be willing and capable of giving informed consent
• Be willing and able to comply with study-related requirements, procedures, and visits
• Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
• Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

You may not qualify if:

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
• Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
• Have a current diagnosis of a progressive neurological disease as determined by the Investigator
• Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
• Have a condition that the Investigator determines would significantly increase perioperative risk
• Significant cervical stenosis
• Any previous history of surgery on the posterior elements (laminectomy, posterior fusion)
• Be benefitting within from an interventional procedure and/or surgery to treat upper limb pain (Subjects should be enrolled at least 30 days from last benefit)
• Have an existing drug pump and/or another active implantable device such as a pacemaker
• Have a condition currently requiring or likely to require the use of MRI or diathermy
• Have metastatic malignant disease or active local malignant disease
• Have a life expectancy of less than 1 year
• Have an active systemic or local infection
• Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
• Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (1)

Nevro Corp.

Redwood City, California, 94065, United States

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brad Gliner

  Nevro Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 11, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)