High-density in Spinal Cord Stimulation: Virtual Expert Registry

Failed Back Surgery Syndrome Clinical Trial

— Discover  

Official title:

High-density in Spinal Cord Stimulation: Virtual Expert Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787265
• Other study ID #: Discover1
• Status: Completed
• Start date: June 2016
• Est. completion date: December 8, 2020

Study information

• Verified date: January 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Device:
• spinal cord stimulation

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Medtronic

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6. — View Citation

Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity with the Numeric Rating Scale (NRS)		The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Primary	Pain relief by pain medication	Questionnaire regarding the amount of pain relief by pain medication	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Primary	The abilities in daily living	The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Primary	The current health status	The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Primary	Subjective sleep quality	Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Primary	Patient's satisfaction	Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	Pain area coverage	The patient has to draw the areas of pain coverage on a body shape figure	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	Paresthesia threshold	Patient indicates the threshold at which he experiences paresthesia	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	HD stim parameters	Questionnaire towards the clinician regarding the ideal high density parameters for this patient	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	Battery efficiency of the neurostimulator	The battery usage will be measured by frequencies to recharge the battery.	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	AdaptiveStim use (in case of Restore Sensor)	Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary	MRI need	Questionnaire regarding the need for MR scans for other medical conditions	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.