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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05177354




Registration number
NCT05177354
Ethics application status
Date submitted
30/11/2021
Date registered
4/01/2022
Date last updated
22/04/2024

Titles & IDs
Public title
Medtronic Closed-Loop Spinal Cord Stimulation System
Scientific title
Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
Secondary ID [1] 0 0
MDT21017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Leg Pain 0 0
Upper Limb Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Inceptiv

Experimental: Treatment -


Treatment: Devices: Inceptiv
Implantable Neurostimulator with Neuro Sense
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in overstimulation sensation
Timepoint [1] 0 0
30 days from device activation
Secondary outcome [1] 0 0
Responder rate for treatment of overall pain
Timepoint [1] 0 0
3 months from device activation
Secondary outcome [2] 0 0
Responder rate for treatment of low-back pain
Timepoint [2] 0 0
3 months from device activation
Secondary outcome [3] 0 0
Responder rate for treatment of leg pain
Timepoint [3] 0 0
3 months from device activation

Eligibility
Key inclusion criteria
- 18 years of age or older

- Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of
the trunk and/or limbs

- If being treated for low-back and/or leg pain,

- the baseline overall^ Visual Analog Scale is = 60 mm and

- baseline back and/or leg pain Visual Analog Scale is =60 mm. ^Average overall
pain in the back and/or leg in the 72 hours prior to the baseline visit, measured
using Visual Analog Scale.

- If being treated for upper limb pain - baseline Visual Analog Scale is = 60 mm for
upper limb pain

- On stable (no change in dose, route, or frequency) prescribed pain medications being
used for back and leg pain or upper limb pain, as determined by the investigator, for
at least 28 days prior to device trial

- Willing and able to provide signed and dated informed consent

- Willing and able to comply with all study procedures and visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral
Vascular Disease of Fontaine Stage III or higher

- Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve
stimulator, deep brain stimulator or an implantable intrathecal drug delivery system

- Currently participating, or plans to participate, in another investigational study
unless written approval is provided by the Medtronic study team

- Major psychiatric comorbidity or other progressive diseases that may confound study
results, as determined by the Investigator

- Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance
abuse), as determined by the Investigator

- Pregnant or planning on becoming pregnant (if female and sexually active, subject must
be using a reliable form of birth control, be surgically sterile, or be at least 2
years post-menopausal)

- Be involved in an injury claim or under current litigation

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sydney Pain Specialists - Bella Vista
Recruitment hospital [2] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [3] 0 0
Australian Medical Research - Hurstville
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [5] 0 0
Sydney Pain Research Centre - Wahroonga
Recruitment hospital [6] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [7] 0 0
Precision Brain Spine and Pain Center - Kew
Recruitment postcode(s) [1] 0 0
2153 - Bella Vista
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
2220 - Hurstville
Recruitment postcode(s) [4] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
4567 - Noosa Heads
Recruitment postcode(s) [7] 0 0
3101 - Kew

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedtronicNeuro
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to further understand the closed-loop feature in chronically
implanted patients by characterizing the efficacy of the next generation, spinal cord
stimulator.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05177354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Russo, MD
Address 0 0
Genesis Research Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05177354