Clinical trial NCT02950831: Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
Official title: Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
BurstDR
spinal cord stimulation
Accelerometry
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: AZ Sint-Augustinus, Wilrijk
name: AZ Middelheim, Antwerpen
name: Erasmus Medical Center
First posted: 2016-11-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Activity Levels
timeFrame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
measure: Change in Sleep Quality
timeFrame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Secondary outcomes:
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: between baseline and 1 month post permanent spinal cord stimulator activation followup
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: between baseline and 2 month post permanent spinal cord stimulator activation followup
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: between baseline and 3 month post permanent spinal cord stimulator activation followup
measure: Change in European Quality of Life 5 Dimensions (EQ-5D)
timeFrame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
measure: Change in European Quality of Life 5 Dimensions (EQ-5D)
timeFrame: between baseline and 1 month post permanent spinal cord stimulator activation followup
measure: Change in European Quality of Life 5 Dimensions (EQ-5D)
timeFrame: between baseline and 2 month post permanent spinal cord stimulator activation followup
measure: Change in European Quality of Life 5 Dimensions (EQ-5D)
timeFrame: between baseline and 3 month post permanent spinal cord stimulator activation followup
measure: Change in Oswestry Disability Index (ODI)
timeFrame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
measure: Change in Oswestry Disability Index (ODI)
timeFrame: between baseline and 1 month post permanent spinal cord stimulator activation followup
measure: Change in Oswestry Disability Index (ODI)
timeFrame: between baseline and 2 month post permanent spinal cord stimulator activation followup
measure: Change in Oswestry Disability Index (ODI)
timeFrame: between baseline and 3 month post permanent spinal cord stimulator activation followup
measure: Change in Activity Levels
timeFrame: between baseline and 1 month post permanent spinal cord stimulator activation followup
measure: Change in Sleep Quality
timeFrame: between baseline and 1 month post permanent spinal cord stimulator activation followup
measure: Change in Activity Levels
timeFrame: between baseline and 2 month post permanent spinal cord stimulator activation followup
measure: Change in Sleep Quality
timeFrame: between baseline and 2 month post permanent spinal cord stimulator activation followup
measure: Change in Activity Levels
timeFrame: between baseline and 3 month post permanent spinal cord stimulator activation followup
measure: Change in Sleep Quality
timeFrame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus
state: Antwerp
city: Antwerpen
country: Belgium
facility: AZ Middelheim
state: Flanders
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: South Holland
Study officials:
affiliation: Abbott Medical Devices
name: Lalit Venkatesan, Ph.D.
role: STUDY_DIRECTOR
References: