Wireless Spinal Cord Stimulation for Chronic Pain

NCT ID: NCT02514590

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-07-31

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.

Conditions

Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Freedom SCS System - 1500 HZ

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

Group Type: EXPERIMENTAL

Freedom SCS System

Intervention Type: 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.

Interventions

Freedom SCS System

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

The Center for Clinical Research, Winston-Salem, NC

OTHER

Sponsor Role: collaborator

Anesthesia Pain Care Consultants, Tamarac, FL, USA

UNKNOWN

Sponsor Role: collaborator

Precision Spine Care, Tyler, TX, USA

UNKNOWN

Sponsor Role: collaborator

Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA

UNKNOWN

Sponsor Role: collaborator

Compass Research LLC, Orlando, FL, USA

UNKNOWN

Sponsor Role: collaborator

USC Spine, Keck hospital of USC, Los Angeles, CA, USA

UNKNOWN

Sponsor Role: collaborator

Curonix LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagy Mekhail

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Nuvo Spine and Sports Institute & Ortho Regenerative Center

Beverly Hills, California, United States

USC Spine Center, Keck Hospital of USC

Los Angeles, California, United States

Compass Research

Orlando, Florida, United States

Anesthesia Pain Care Consultants

Tamarac, Florida, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Precision Spine Care

Tyler, Texas, United States

Countries

United States

Other Identifiers

30-00113

Identifier Type: -

Identifier Source: org_study_id