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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001062011
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
2/12/2010
Date last updated
3/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the
Treatment of Chronic Pain
Scientific title
A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the
Treatment of Chronic Pain
Secondary ID [1] 252887 0
02-SMI-2010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Neuropathic Pain 258419 0
Condition category
Condition code
Anaesthesiology 258585 258585 0 0
Pain management
Musculoskeletal 258860 258860 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention involves the placement of epidural leads that provide stimulation. Stimulation intensity and the amount of of stimulation during the day is controlled by the subject to the desired levels during the duration of the clinical trial. The mechanism of action is unknown. Subject will be followed up for 12 months following implantation neurostimulator system. Trial duration is expected to be approximately 15-18 months.
Intervention code [1] 257414 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259430 0
Device Safety as determined by adverse event reporting. Adverse event profiles are expected to be similar to currently approved devices. These can include infection, lead migration, etc.
Timepoint [1] 259430 0
Multiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.
Primary outcome [2] 259713 0
Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias.
Timepoint [2] 259713 0
Multiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.
Secondary outcome [1] 265978 0
Pain relief (VAS)
Timepoint [1] 265978 0
Baseline, 1, 3, 6 and 12 months
Secondary outcome [2] 265979 0
Quality of Life (EQ-5D)
Timepoint [2] 265979 0
Baseline, 1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
1) Male or female >= 18 years old
2) Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months
3) Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain
4) Minimum baseline pain rating of 60 mm on the VAS
5) Stable pain medication dosage for at least 30 days
6) Stable neurologic function in the past 30 days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2) Escalating or changing pain condition within the past month as evidenced by investigator examination
3) Subject is currently involved in medically related litigation

4) Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump

5) Subject currently has an active infection
6) Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device

7) Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation

8) Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257854 0
Commercial sector/Industry
Name [1] 257854 0
Spinal Modulation
Address [1] 257854 0
1135 O'Brien Dr.
Menlo Park, CA 94025
Country [1] 257854 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Spinal Modulation
Address
1135 O'Brien Dr.
Menlo Park, CA 94025
Country
United States of America
Secondary sponsor category [1] 257060 0
None
Name [1] 257060 0
N/A
Address [1] 257060 0
N/A
Country [1] 257060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259888 0
Ethics committee address [1] 259888 0
Ethics committee country [1] 259888 0
Date submitted for ethics approval [1] 259888 0
14/08/2010
Approval date [1] 259888 0
Ethics approval number [1] 259888 0

Summary
Brief summary
The purpose of this study is to determine the safety and device performance of the Spinal Modulation Neurostimulation System in the treatment of chronic pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31785 0
Address 31785 0
Country 31785 0
Phone 31785 0
Fax 31785 0
Email 31785 0
Contact person for public queries
Name 15032 0
Jeffery Kramer, PhD
Address 15032 0
Spinal Modulation
1135 O'Brien Dr.
Menlo Park, CA 94025
Country 15032 0
United States of America
Phone 15032 0
+1-650-543-6800, ext. 6836
Fax 15032 0
Email 15032 0
jeff@spinalmodulation.com
Contact person for scientific queries
Name 5960 0
Jeffery Kramer, PhD
Address 5960 0
Spinal Modulation
1135 O'Brien Dr.
Menlo Park, CA 94025
Country 5960 0
United States of America
Phone 5960 0
+1-650-543-6800, ext. 6836
Fax 5960 0
Email 5960 0
jeff@spinalmodulation.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary