Objective Assessment of Activity and Sleep Quality In Bur... | NCT02950831

NCT02950831

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
AZ Sint-Augustinus, Wilrijk	UNKNOWN
AZ Middelheim, Antwerpen	UNKNOWN
Erasmus Medical Center	OTHER

Label	Type	Description	Intervention Names
Activity and sleep quality recording	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Accelerometry	Other	Record of activity levels using a wrist worn accelerometer	Activity and sleep quality recording

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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)

Name	Affiliation	Role
Lalit Venkatesan, Ph.D.	Abbott Medical Devices	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
AZ Sint-Augustinus		Wilrijk	Antwerp	2610	Belgium
AZ Middelheim

ID	Title	Description
FG000	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 Accelerometry: Record of activity levels using a wrist worn accelerometer

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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 Accelerometry: Record of activity levels using a wrist worn accelerometer

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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 change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 2 patients.

Posted

Mean

Standard Deviation

change in MVPA h/day from baseline value

between baseline and the end of spinal cord stimulation trial period (average of 1 month)

ID	Title	Description
OG000	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 Accelerometry: Record of activity levels using a wrist worn accelerometer

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 Accelerometry: Record of activity levels using a wrist worn accelerometer

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Increased pain/inadequate pain relief that required device reprogramming	Nervous system disorders		Non-systematic Assessment

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms