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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

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.

Interventions

  • Other: Accelerometry
    • Record of activity levels using a wrist worn accelerometer

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Activity Levels
    • Time Frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
    • 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.
  • Change in Sleep Quality
    • Time Frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
    • Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Collaborator
    • AZ Sint-Augustinus, Wilrijk
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lalit Venkatesan, Ph.D., Study Director, Abbott Medical Devices

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