Clinical trial NCT02514590: Wireless Spinal Cord Stimulation for Chronic Pain
Official title: Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Curonix LLC
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
name: The Center for Clinical Research, Winston-Salem, NC
name: Anesthesia Pain Care Consultants, Tamarac, FL, USA
name: Precision Spine Care, Tyler, TX, USA
name: Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA
name: Compass Research LLC, Orlando, FL, USA
name: USC Spine, Keck hospital of USC, Los Angeles, CA, USA
First posted: 2015-08-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain

Detailed description: This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.

Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.

Stimulators will be placed at the following sites to target the painful area:

• Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years of age at time of informed consent;
* Subjects have been diagnosed with chronic back or back and leg pain with an average VAS \> 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
* Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
* Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
* Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
* Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
* Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
* Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
* Subject is male or non-pregnant female;
* Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
* Subject is capable of giving informed consent;
* Subject lives within reasonable distance from the study site (circumference of 50 miles).

Exclusion Criteria:

* Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
* Unresolved Malignancies in last six months;
* Subject has post-herpetic neuralgia (shingles);
* Subject has an active systemic infection or is immune-compromised;
* Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
* Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
* Bleeding complications or coagulopathy issues;
* Pregnant/lactating or not using adequate birth control;
* A life expectancy of less than one year;
* Any active implanted device whether turned off or on;
* A previous SCS experience;
* Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.

Primary outcomes:
measure: Pain Score
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage change in VAS Back from baseline
timeFrame: 6 Months
measure: Percentage change in VAS Leg from baseline
timeFrame: 6 Months
measure: Oswestry Disability Index (ODI) Score
timeFrame: 6 Months
measure: Patient Satisfaction
timeFrame: 6 Months
measure: Disability Score
timeFrame: 6 Months
measure: Sleep Quality
timeFrame: 6 Months
measure: Procedure time
timeFrame: 7 Days post implant
measure: Opioid Reduction
timeFrame: 6 Months
measure: Adverse Events
timeFrame: 6 Months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Nuvo Spine and Sports Institute & Ortho Regenerative Center
state: California
city: Los Angeles
country: United States
facility: USC Spine Center, Keck Hospital of USC
state: California
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Tamarac
country: United States
facility: Anesthesia Pain Care Consultants
state: Florida
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: Nagy Mekhail
role: PRINCIPAL_INVESTIGATOR
References: