NCT02950831

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2016

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 29, 2019

Completed
Last Updated

August 29, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

October 27, 2016

Results QC Date

November 19, 2018

Last Update Submit

July 24, 2019

Conditions

Chronic Pain

Keywords

Chronic PainBurstDRspinal cord stimulationAccelerometry

Outcome Measures

Primary Outcomes (2)

  • 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 (18)

  • Change in Visual Analog Scale (VAS) for Pain

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

  • Change in Visual Analog Scale (VAS) for Pain

    between baseline and 1 month post permanent spinal cord stimulator activation followup

  • Change in Visual Analog Scale (VAS) for Pain

    between baseline and 2 month post permanent spinal cord stimulator activation followup

  • Change in Visual Analog Scale (VAS) for Pain

    between baseline and 3 month post permanent spinal cord stimulator activation followup

  • Change in European Quality of Life 5 Dimensions (EQ-5D)

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

  • +13 more secondary outcomes

Study Arms (1)

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

Interventions

AccelerometryOTHER

Record of activity levels using a wrist worn accelerometer

Also known as: wrist worn accelerometers
Activity and sleep quality recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AZ Sint-Augustinus

Wilrijk, Antwerp, 2610, Belgium

Location

AZ Middelheim

Antwerp, Flanders, 2020, Belgium

Location

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Filippo Agnesi
Organization
St. Jude Medical
filippo.agnesi@abbott.com
14694184987

Study Officials

  • Lalit Venkatesan, Ph.D.

    Abbott Medical Devices

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 29, 2019

Results First Posted

August 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)BE(2)