Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stimwave HF SCS Pilot Study (HFSCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02787252
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Stimwave Technologies

Brief Summary:
The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.

Condition or disease Intervention/treatment Phase
FBSS Device: Implant procedure, Freedom Spinal Cord Stimulation System Not Applicable

Detailed Description:

This is a non-blinded, short-term study for a maximum duration of 12 weeks in which 6 patients will receive a Freedom SCS System. Subjects will have chronic, intractable pain of the trunk and/or lower limbs refractory to standard medical treatment; including unilateral or bilateral pain. Stimulators will be placed in the epidural space and over exiting nerve roots at vertebrae levels:

A. Bilateral T9-T10 epidural; B. Bilateral L1-L4 epidural. All Patients will be treated below perception threshold with High Frequency settings (10.000 Hz, 30 μs).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Clinical Pilot Study of High Frequency Wireless Spinal Cord Stimulation (SCS) in the Treatment of Chronic Pain With The Freedom Spinal Cord Stimulatory
Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: HF DRG
HF DRG Implants
Device: Implant procedure, Freedom Spinal Cord Stimulation System
A needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back.




Primary Outcome Measures :
  1. Primary Efficacy Outcome (VAS) [ Time Frame: 12 weeks post-implant ]
    The primary outcome is defined as the percentage of subjects who respond (50% average or more pain relief for back and leg pain) to SCS therapy at the end of 12 weeks post-implant of the system as compared to baseline with no increase in medication. The primary outcome will be measured with the VAS (100 mm line).

  2. Primary Safety Outcome (Adverse Events) [ Time Frame: 12 weeks post-implant ]
    Incidence and severity of device related adverse events during the study


Secondary Outcome Measures :
  1. VAS [ Time Frame: 12 weeks post-implant ]
    Percentage change from baseline in VAS for back and leg pain

  2. ODI [ Time Frame: 12 weeks post-implant ]
    Change from baseline in functionality using the ODI score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria:

    A. Subject is ≥ 18 years of age at time of informed consent;

    B. Subjects have been diagnosed with chronic, intractable pain of the trunk and/or lower limbs with a VAS > 5cm (on a 10-cm scale);

    C. Subject diagnosis with chronic pain refractory to conventional medical management for at least 6 months prior to enrollment;

    D. 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;

    E. Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;

    F. 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;

    G. Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;

    H. Subject is male or non-pregnant female;

    I. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of the investigator, using face-to-face encounters and the psychological testing described in the measures;

    J. Patient is capable of giving informed consent;

    K. Patient lives within reasonable distance from the study site (circumference of 75 km).

  2. Exclusion Criteria:

A. Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);

B. Malignancies;

C. Subject has post-herpetic neuralgia (shingles);

D. Subject has an active systemic infection or is immune-compromised.

E. Based on the medical opinion of the Principal Investigator 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;

F. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;

G. Insulin-dependent diabetic who is not controlled through diet and/or medication;

H. Bleeding complications or coagulopathy issues;

I. Pregnant/lactating or not using adequate birth control;

J. A life expectancy of less than one year;

K. Any active implanted device whether turned off or on;


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): NCT02787252


Locations
Layout table for location information
Belgium
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Sponsors and Collaborators
Stimwave Technologies

Layout table for additonal information
Responsible Party: Stimwave Technologies
ClinicalTrials.gov Identifier: NCT02787252     History of Changes
Other Study ID Numbers: 30-00178
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017