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
|Condition or disease||Intervention/treatment||Phase|
|FBSS||Device: Implant procedure, Freedom Spinal Cord Stimulation System||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 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).
- Primary Safety Outcome (Adverse Events) [ Time Frame: 12 weeks post-implant ]Incidence and severity of device related adverse events during the study
- VAS [ Time Frame: 12 weeks post-implant ]Percentage change from baseline in VAS for back and leg pain
- ODI [ Time Frame: 12 weeks post-implant ]Change from baseline in functionality using the ODI score
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
|Roeselare, West-Vlaanderen, Belgium, 8800|