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High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)

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ClinicalTrials.gov Identifier: NCT02787265
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

Brief Summary:
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.

Condition or disease Intervention/treatment
Failed Back Surgery Syndrome Device: spinal cord stimulation

Detailed Description:
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: High-density in Spinal Cord Stimulation: Virtual Expert Registry
Study Start Date : June 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
Device: spinal cord stimulation
Other Name: high density spinal cord stimulation




Primary Outcome Measures :
  1. Pain intensity with the Numeric Rating Scale (NRS) [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
  2. Pain relief by pain medication [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Questionnaire regarding the amount of pain relief by pain medication

  3. The abilities in daily living [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.

  4. The current health status [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.

  5. Subjective sleep quality [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

  6. Patient's satisfaction [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale


Secondary Outcome Measures :
  1. Pain area coverage [ Time Frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    The patient has to draw the areas of pain coverage on a body shape figure

  2. Paresthesia threshold [ Time Frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Patient indicates the threshold at which he experiences paresthesia

  3. HD stim parameters [ Time Frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Questionnaire towards the clinician regarding the ideal high density parameters for this patient

  4. Battery efficiency of the neurostimulator [ Time Frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    The battery usage will be measured by frequencies to recharge the battery.

  5. AdaptiveStim use (in case of Restore Sensor) [ Time Frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves

  6. MRI need [ Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. ]
    Questionnaire regarding the need for MR scans for other medical conditions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Criteria

Inclusion Criteria:

  • Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
  • Age > 18 years
  • Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
  • Patient has been informed of the study procedures and has given written informed consent
  • Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

  • Expected inability of patients to receive or properly operate the spinal cord stimulation system
  • History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
  • Active malignancy
  • Addiction to any of the following drugs, alcohol (5E/day) and/or medication
  • Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
  • Immune deficiency (HIV positive, immunosuppressiva, etc.)
  • Life expectancy < 1 year
  • Local infection or other skin disorder at site of incision
  • Pregnancy
  • Other implanted active medical device

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): NCT02787265


Contacts
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Contact: Maarten Moens, Prof. dr. maarten.moens@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Brussel, Belgium
Contact: Maarten Moens         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Medtronic
Additional Information:

Publications:
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Responsible Party: Moens Maarten, Prof. dr., Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02787265    
Other Study ID Numbers: Discover1
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Moens Maarten, Universitair Ziekenhuis Brussel:
High density spinal cord stimulation
Virtual expert registry
Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Postoperative Complications
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations