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

NCT ID: NCT02950831

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-03-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Accelerometry

Intervention Type: OTHER

Record of activity levels using a wrist worn accelerometer

Interventions

Accelerometry

Record of activity levels using a wrist worn accelerometer

Intervention Type: OTHER

Other Intervention Names

wrist worn accelerometers

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Augustinus, Wilrijk

UNKNOWN

Sponsor Role: collaborator

AZ Middelheim, Antwerpen

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lalit Venkatesan, Ph.D.

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

AZ Sint-Augustinus

Wilrijk, Antwerp, Belgium

AZ Middelheim

Antwerp, Flanders, Belgium

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Belgium; Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10133

Identifier Type: -

Identifier Source: org_study_id