ANZCTR - Registration

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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]

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

Leg pain

Neuropathic pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Neurological

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]

Diagnosis / Prognosis

Comparator / control treatment

VitalPatch is used as the reference standard

Control group

Active

Outcomes

Primary outcome [1]

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]

Visit 3 - 28-42 days post permanent SCS implant surgery

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment postcode(s) [1]

2220 - Hurstville

Recruitment postcode(s) [2]

2042 - Newtown

Recruitment postcode(s) [3]

3101 - Kew

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Medtronic External Research Program

Address [1]

Medtronic
2 Alma Road
Macquarie Park
NSW, 2113
Australia

Country [1]

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]

Commercial sector/Industry

Name [1]

FiveCorners

Address [1]

13/76 Reserve Road
Artarmon
NSW 2064
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

123 Glen Osmond Road
Eastwood 
SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/05/2019

Approval date [1]

03/09/2019

Ethics approval number [1]

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

Dr Richard Sullivan

Address

Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101

Country

Australia

Phone

+61 3 8862 0000

Fax

drsullivan@precisionhealth.com.au

Contact person for public queries

Name

Richard Sullivan

Address

Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101

Country

Australia

Phone

+61 3 8862 0000

Fax

drsullivan@precisionhealth.com.au

Contact person for scientific queries

Name

Richard Sullivan

Address

Precision Brain, Spine and Pain Centre
Lower Ground, 115 Cotham Road,
Kew VICTORIA 3101

Country

Australia

Phone

+61 3 8862 0000

Fax

drsullivan@precisionhealth.com.au

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 drsullivan@precisionhealth.com.au.
To gain access, data requestors will need to sign a data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1968	Study protocol			drsullivan@precisionhealth.com.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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