Wireless Spinal Cord Stimulation for Chronic Pain

NCT02514590 | Completed DMC

• 1 other identifier: 30-00113
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

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

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Score

  A 50% reduction in VAS scores when compared to baseline.

  6 Months

Secondary Outcomes (9)

• Percentage change in VAS Back from baseline

  6 Months

• Percentage change in VAS Leg from baseline

  6 Months

• Oswestry Disability Index (ODI) Score

  6 Months

• Patient Satisfaction

  6 Months

• Disability Score

  6 Months

Study Arms (1)

Freedom SCS System - 1500 HZ

EXPERIMENTAL

Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area.

Device: Freedom SCS System

Interventions

Freedom SCS System DEVICE

This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.

Freedom SCS System - 1500 HZ

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curonix LLC: lead
• The Cleveland Clinic: collaborator
• The Center for Clinical Research, Winston-Salem, NC: collaborator
• Anesthesia Pain Care Consultants, Tamarac, FL, USA: collaborator
• Precision Spine Care, Tyler, TX, USA: collaborator
• Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA: collaborator
• Compass Research LLC, Orlando, FL, USA: collaborator
• USC Spine, Keck hospital of USC, Los Angeles, CA, USA: collaborator

Study Sites (7)

Nuvo Spine and Sports Institute & Ortho Regenerative Center

Beverly Hills, California, 90212, United States

Location

USC Spine Center, Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Anesthesia Pain Care Consultants

Tamarac, Florida, 33301, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nagy Mekhail

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

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: July 31, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (7)