Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000733178
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
16/05/2019
Date last updated
21/12/2020
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of positional data in the Intellis implantable neurostimulator in patients with neuropathic pain.
Scientific title
Validation of positional data in the Intellis implantable neurostimulator in patients with neuropathic pain.
Secondary ID [1] 297967 0
IntellisVP2019
Universal Trial Number (UTN)
U1111-1231-6428
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower back pain 312372 0
Leg pain 312377 0
Neuropathic pain 312653 0
Condition category
Condition code
Musculoskeletal 310929 310929 0 0
Other muscular and skeletal disorders
Neurological 310930 310930 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Spinal Cord Stimulation (SCS) is used to treat patients with chronic lower back and leg pain.
Adult patients with neuropathic back and/or leg pain who are candidates for Medtronic Intellis SCS therapy and who have completed a trial period of spinal cord stimulation and have opted to have a permanent spinal cord stimulator will be recruited into the study. These patients are undergoing standard care for their condition.

The Medtronic Intellis SCS incorporates an accelerometer, which aside from allowing adjustments to stimulation in response to patient’s position, provides the opportunity for objective long term assessment of routine physical activity patients with chronic pain.

Patients will be asked to wear the VitalPatch, a disposable, adhesive device worn on the upper left chest, which provides continuous monitoring of patient’s health and physiological measurements for five days to collect positional information for comparison with Intellis system. The triaxial accelerometer imbedded in the VitalPatch has demonstrated validity making it suitable for use in validation studies. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear.

Patient data from the Vital Patch, in-clinic controlled testing, home wear and diary recording will be used to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Medtronic Intellis SCS. In-clinic controlled testing will be conducted by the study coordinator.
Intervention code [1] 314187 0
Diagnosis / Prognosis
Comparator / control treatment
VitalPatch is used as the reference standard
Control group
Active

Outcomes
Primary outcome [1] 319745 0
The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The positional data variable being evaluated are: walking, sitting, standing, lying (supine, prone, left side, right side)
Timepoint [1] 319745 0
Visit 3 - 28-42 days post permanent SCS implant surgery
Secondary outcome [1] 369386 0
The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase. The positional data variable being evaluated are: walking, sitting, standing, lying (supine, prone, left side, right side)
Timepoint [1] 369386 0
Conclusion of 5 days VitalPatch wear

Eligibility
Key inclusion criteria
1. adult patients (18 to 70 years of age)
2. diagnosed with chronic intractable pain of the lower back and/or leg (s)
3. have passed a neuropsychological screen as per standard of care for SCS
4. have opted to undergo permanent SCS implant
5. able to move freely between sitting, standing, lying and walking positions unassisted
6. be willing and capable of giving informed consent
7. be willing and able to comply with study-related requirement, procedures and visits
8. females of childbearing age must have a negative urine pregnancy test at baseline (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. have a medical condition or pain in other area (s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2. have evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact mobility, severe sleep disturbance, compliance of intervention and/or ability to evaluate treatment outcomes
3. have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
4. have a condition currently requiring or likely to require the use of MRI or diathermy
5. have been diagnosed with a malignancy or has an active systemic infection
6. be pregnant or nursing
7. have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser
8. are under active worker’s compensation (or personal injury) litigation or adjudication

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
No formal sample size calculations have been undertaken. Standard errors for Intellis data are unavailable and there are too many variables to be taken into account. The estimated sample size has been based on sample size for similar studies.

This is a sample size of convenience, wherein the study population will be highly dependent on the recruitment of patients who opt to have the permanent SCS. Three sites have been employed to facilitate recruitment. Currently, these sites are able to recruit one to two permanent SCS research participant a month. The study is projected to run for 12 months, enabling 25 patients to be recruited for the study.

All data (Intellis, VitalPatch biosensor and manually collected) will be stored in SPSS for further statistical analysis. Intellis data will be validated against the VitalPatch and manually annotated data. Statistical analysis will be done to determine the true variance, error variance and reliability of the postural data collected.

Descriptive statistics will be calculated for each variable. Depending on the normality of the data appropriate analysis to assess agreement between devices will be conducted.
An interim analysis will be conducted at six months or when data collection has been completed for 12 patients. If the data validity findings appear to be consistent the study will be stopped.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
VitalPatch could not be provided for use in the study.
Date of first participant enrolment
Anticipated
7/10/2019
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
20/11/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 26284 0
2220 - Hurstville
Recruitment postcode(s) [2] 26285 0
2042 - Newtown
Recruitment postcode(s) [3] 26286 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 302486 0
Commercial sector/Industry
Name [1] 302486 0
Medtronic External Research Program
Country [1] 302486 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Precision Health Foundation
Address
PO Box 3096,
Cotham LPO,
Kew
VICTORIA 3101
Country
Australia
Secondary sponsor category [1] 302392 0
Commercial sector/Industry
Name [1] 302392 0
FiveCorners
Address [1] 302392 0
13/76 Reserve Road
Artarmon
NSW 2064
Australia
Country [1] 302392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303148 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 303148 0
123 Glen Osmond Road
Eastwood
SA 5063

Ethics committee country [1] 303148 0
Australia
Date submitted for ethics approval [1] 303148 0
31/05/2019
Approval date [1] 303148 0
03/09/2019
Ethics approval number [1] 303148 0
2019-03-285

Summary
Brief summary
Physical activity is impaired by chronic pain and there is evidence that the distribution of activities over the course of a day varies between persons with chronic low back pain and healthy individuals. Spinal Cord Stimulation can improve chronic pain which can lead to increased physical activity and improved quality of life in chronic pain patients. The objective measures of physical activity may be more useful than self-report to both patients and providers. The incorporation of accelerometry into Spinal Cord Stimulation, aside from allowing adjustment of stimulation in response to the patient’s position, provides the opportunity to objectively measure activity following Spinal Cord Stimulation implantation. Outcomes, including physical activity, should be evaluated using validated instruments to ensure accuracy and reliability. There is a need for the activity measured by the accelerometer imbedded in the Medtronic Intellis Spinal Cord Stimulator to be validated against credible measurements. Accelerometry is considered gold standard for physical activity measurement and the accelerometer imbedded in the disposable Vital Patch has demonstrated validity.

The aim of this study is to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Intellis System.

Patients who have completed a trial period of spinal cord stimulation and have opted to have a permanent Medtronic Intellis Spinal Cord Stimulator will be recruited into the study. Participants will be asked to wear the VitalPatch, a disposable adhesive device with an embedded accelerometer for five days to collect positional information for comparison with Intellis system. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear.

The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92642 0
Dr Richard Sullivan
Address 92642 0
Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101
Country 92642 0
Australia
Phone 92642 0
+61 3 8862 0000
Fax 92642 0
Email 92642 0
[email protected]
Contact person for public queries
Name 92643 0
Dr Richard Sullivan
Address 92643 0
Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101
Country 92643 0
Australia
Phone 92643 0
+61 3 8862 0000
Fax 92643 0
Email 92643 0
[email protected]
Contact person for scientific queries
Name 92644 0
Dr Richard Sullivan
Address 92644 0
Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101
Country 92644 0
Australia
Phone 92644 0
+61 3 8862 0000
Fax 92644 0
Email 92644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the published results, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Individual participant data meta-analysis.
How or where can data be obtained?
Requests should be directed to [email protected].
To gain access, data requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1968Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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