Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation (OASIS)

The purpose of this study is to assess feasibility of using wearable sensors to capture objective assessments of patient's activity and sleep quality during the spinal cord stimulation (SCS) treatment continuum.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Accelerometry

Detailed Description

Eligible patients will undergo standard clinical care using BurstDR SCS and will be asked to wear a wrist worn accelerometer for a baseline period, during SCS trial and for 3 months after activation of the SCS stimulation.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • AZ Sint-Augustinus
  • Flanders
    • Antwerpen, Flanders, Belgium, 2020
      • AZ Middelheim
• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is able to provide informed consent to participate in the study;
• Subject is 18 years of age or older;
• Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy;
• Subjects with the diagnosis of failed back surgery syndrome or chronic intractable trunk and/or lower limb pain and are eligible for a SCS trial;
• Subjects have an average trunk pain VAS score of at least 6.0 out of 10.0, and/or lower limb pain VAS score of at least 6.0 out of 10.0;
• Subject is on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device;
• Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
• Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
• Subject agrees to wear the wearable sensor for the duration of the study;
• Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study

Exclusion Criteria:

• Subject is currently participating in a clinical investigation that includes an active treatment arm;
• Subject has been implanted with or participated in a trial period for a neurostimulation system;
• Non- ambulatory subjects who are not expected to become ambulatory after receiving neurostimulation;
• Subject diagnosed with fibromyalgia or chronic fatigue;
• Subject has an infusion pump;
• Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
• Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus;
• Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
• Subject is immunocompromised;
• Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment;
• Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
• Subject has history of cancer requiring active treatment in the last 12 months;
• Subject has an existing medical condition that is likely to require the use of diathermy in the future;
• Subject has documented history of allergic response to titanium or silicone;
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
• Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activity and sleep quality recording; Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment	Other: Accelerometry; Record of activity levels using a wrist worn accelerometer; Other Names: wrist worn accelerometers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Activity Levels	Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.	between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Sleep Quality	Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.	between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) for Pain	Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)	between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Visual Analog Scale (VAS) for Pain	Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)	between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Visual Analog Scale (VAS) for Pain	Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)	between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Visual Analog Scale (VAS) for Pain	Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)	between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)	Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life.	between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in European Quality of Life 5 Dimensions (EQ-5D)	Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life	between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)	Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life	between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)	Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life	between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)	Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.	between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Oswestry Disability Index (ODI)	Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.	between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)	Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.	between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)	Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.	between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Activity Levels	Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.	between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality	Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.	between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Activity Levels	Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.	between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality	Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.	between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Activity Levels	Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.	between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality	Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.	between baseline and 3 month post permanent spinal cord stimulator activation followup

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Erasmus Medical Center; AZ Sint-Augustinus, Wilrijk; AZ Middelheim, Antwerpen

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Pain; Accelerometry; spinal cord stimulation; BurstDR
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: SJM-CIP-10133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO