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Wireless High Frequency Spinal Cord Stimulation for Chronic Pain

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ClinicalTrials.gov Identifier: NCT02514590
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
The Cleveland Clinic
The Center for Clinical Research, Winston-Salem, NC
Anesthesia Pain Care Consultants, Tamarac, FL, USA
Precision Spine Care, Tyler, TX, USA
Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA
Compass Research LLC, Orlando, FL, USA
USC Spine, Keck hospital of USC, Los Angeles, CA, USA
Information provided by (Responsible Party):
Stimwave Technologies

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 utilizing high frequency (10,000 Hz) waveforms in comparison to traditional stimulation settings.

Condition or disease Intervention/treatment Phase
Back Pain Device: Freedom SCS System - High Frequency Device: Freedom SCS System - Low Frequency Not Applicable

Detailed Description:

This is a multi-center, prospective, randomized study in which subjects will receive a Freedom SCS System and be randomized 1:1 to receive either HF (10,000 Hz) or LF (5 Hz to 1500 Hz) stimulation parameters. Enrollment will continue until 80 responders at end of trial have been identified. A description of the Freedom SCS System can be found in Appendix A.

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 randomized into either the test (high frequency) or control (low frequency) group 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:

  • High Frequency (HF) Group: 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).
  • Low Frequency (LF) Group: Epidural Space covering vertebrae level determined by paresthesia mapping for painful area.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Randomized, Controlled Clinical Trial of Wireless High Frequency Spinal Cord Stimulation to Demonstrate Non-Inferiority in the Treatment of Chronic Pain as Compared to Traditional Stimulation
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Freedom SCS System - High Frequency
High Frequency (HF) Group: 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).
Device: Freedom SCS System - High Frequency
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 10kHz therapy.

Active Comparator: Freedom SCS System - Low Frequency
Low Frequency (LF) Group: Epidural Space covering vertebrae level determined by paresthesia mapping for painful area.
Device: Freedom SCS System - Low Frequency
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 therapy.




Primary Outcome Measures :
  1. Pain Score [ Time Frame: 6 Months ]
    A 50% reduction in VAS scores when compared to baseline.


Secondary Outcome Measures :
  1. Percentage change in VAS Back from baseline [ Time Frame: 6 Months ]
    The percentage reduction in VAS back pain

  2. Percentage change in VAS Leg from baseline [ Time Frame: 6 Months ]
    The percentage reduction in VAS leg pain

  3. Oswestry Disability Index (ODI) Score [ Time Frame: 6 Months ]
    The change from baseline in functionality using the ODI

  4. Patient Satisfaction [ Time Frame: 6 Months ]
    The change in satisfaction as measured by Patient Global Impression of Change

  5. Disability Score [ Time Frame: 6 Months ]
    The change in European Quality of Life 5 Dimension

  6. Sleep Quality [ Time Frame: 6 Months ]
    Frequency of sleep disturbances reported from diary

  7. Procedure time [ Time Frame: 7 Days post implant ]
    The time measured to implant the device from operative notes

  8. Opioid Reduction [ Time Frame: 6 Months ]
    The reduction in opioids as reported by patient prescription

  9. Adverse Events [ Time Frame: 6 Months ]
    The incidence of device related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514590


Locations
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United States, California
Nuvo Spine and Sports Institute & Ortho Regenerative Center
Beverly Hills, California, United States, 90212
USC Spine Center, Keck Hospital of USC
Los Angeles, California, United States, 90033
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
Anesthesia Pain Care Consultants
Tamarac, Florida, United States, 33301
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Stimwave Technologies
The Cleveland Clinic
The Center for Clinical Research, Winston-Salem, NC
Anesthesia Pain Care Consultants, Tamarac, FL, USA
Precision Spine Care, Tyler, TX, USA
Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA
Compass Research LLC, Orlando, FL, USA
USC Spine, Keck hospital of USC, Los Angeles, CA, USA
Investigators
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Principal Investigator: Nagy Mekhail The Cleveland Clinic

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Responsible Party: Stimwave Technologies
ClinicalTrials.gov Identifier: NCT02514590     History of Changes
Other Study ID Numbers: 30-00113
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms