Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001263987
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
9/12/2011
Date last updated
9/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Automatic Control of Spinal Cord Stimulation
Scientific title
In patients with chronic pain implanted with spinal cord stimulator trial leads, do recordings of spinal cord potentials and automatic control of stimulation compared to standard manual control allow improvements to patient experience of treatment and pain relief
Secondary ID [1] 273570 0
None
Universal Trial Number (UTN)
U1111-1126-1450
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 279312 0
Condition category
Condition code
Anaesthesiology 279503 279503 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have already been implanted with a commercial trial spinal cord stimulation leads will have their implanted leads temporarily connected to a new spinal cord stimulation and recording system. The new system will record nerve responses from the spinal cord stimulation and use those responses to automatically control the stimulation. Patients will be tested in 1 or 2 sessions of up to 4 hours each during their usual trial stimulation period of 4-7 days. Different stimulation paradigms will be tested within subject, crossing-over between automatic control and standard manual control, with a duration in each arm of several minutes up to an hour, with no washout period. Each stimulation paradigm will be tested during various posture changes.
The aims of the study are:
1. To determine if the nerve response to stimulation recorded from the spinal cord can be used to maintain the stimulation at a constant and comfortable level for the patient.
2. Measuring from the spinal cord to optimise the stimulator settings automatically.
3. Determine different stimulation patterns to provide pain relief without the patient feeling the stimulation.
4. To determine if a patient’s pain can be detected from the nerve signals measured in the spinal cord.
Intervention code [1] 283827 0
Treatment: Devices
Comparator / control treatment
Standard manual control of stimulation, requiring the patient to manually control the strength of stimulation with a handheld controller during different postural changes. The manual control treatment will be conducted within subject, within the same session as the automatic control treatment, with duration of several minutes to an hour and no washout between treatments
Control group
Active

Outcomes
Primary outcome [1] 286067 0
Patient verbal rating of stimulation strength from 0 to 10 (nothing to maximum possible strength) and recorded in a computer questionnaire spreadsheet
Timepoint [1] 286067 0
Measured at different postures and with different stimulation types in one experimental session
Primary outcome [2] 286068 0
Patient verbal rating of the percentage of stimulation coverage of total pain areas and recorded in a computer questionnaire spreadsheet
Timepoint [2] 286068 0
Measured at different postures and with different stimulation types in one experimental session
Secondary outcome [1] 295065 0
Patient verbal rating of pain relief on a Numerical Rating Scale of 0-10 (no pain to maximum possible pain) and recorded in a computer questionnaire spreadsheet
Timepoint [1] 295065 0
Measured with different stimulation types in one experimental session

Eligibility
Key inclusion criteria
Patients implanted with a commercially available electrode lead who are part of a routine clinical trial stimulation program prior to possible permanent implant.
Patients are capable of fulfilling the requirements of this protocol including reporting of patient percepts.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients implanted with a commercially available electrode lead who have had complications such that the implanted electrodes are not able to stimulate and record over the spinal cord.

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)
Subjects are enrolled during a trial spinal cord stimulation period. Subjects are selected for the trial stimulation based on clinical needs and then recruited for the study based on inclusion/exclusion criteria. Some or all treatments (stimulation types) are tested non-randomly in all patients
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284303 0
Other Collaborative groups
Name [1] 284303 0
National ICT Australia Ltd
Country [1] 284303 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National ICT Australia Ltd
Address
Level 5,
13 Garden St,
Eveleigh NSW 2015
Country
Australia
Secondary sponsor category [1] 283249 0
None
Name [1] 283249 0
Address [1] 283249 0
Country [1] 283249 0
Other collaborator category [1] 260367 0
Hospital
Name [1] 260367 0
Pain Management Research Institute
Address [1] 260367 0
Kolling Institute
Royal North Shore Hospital
St Leonards, NSW 2065
Country [1] 260367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286265 0
Northern Sydney Central Coast Health Human Research Ethics Committee
Ethics committee address [1] 286265 0
Research Office
Northern Sydney Central Coast Health
St Leonards NSW 2065
Ethics committee country [1] 286265 0
Australia
Date submitted for ethics approval [1] 286265 0
21/06/2011
Approval date [1] 286265 0
06/10/2011
Ethics approval number [1] 286265 0
1106-212M

Summary
Brief summary
This study uses a newly­ developed spinal cord stimulator and measurement system. The aims of the study are:
1. To determine if the nerve response to stimulation recorded from the spinal cord can be used to maintain the stimulation at a constant and comfortable level for the patient.
2. To make measurements from the spinal cord to optimise the stimulator settings automatically.
3. To determine different stimulation patterns to provide pain relief without the patient feeling the stimulation.
4. To determine if a patient’s pain can be detected from the nerve signals measured in the spinal cord.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33474 0
Address 33474 0
Country 33474 0
Phone 33474 0
Fax 33474 0
Email 33474 0
Contact person for public queries
Name 16721 0
Linda Critchley
Address 16721 0
Clinical Research Scientist
Pain Management & Research Centre
Royal North Shore Hospital
St Leonards NSW 2065
Country 16721 0
Australia
Phone 16721 0
+61 2 9926 6451
Fax 16721 0
Email 16721 0
[email protected]
Contact person for scientific queries
Name 7649 0
Robert Gorman PhD
Address 7649 0
Principal Researcher,
NICTA, Implant Systems,
Level 5,
13 Garden St,
Eveleigh NSW 2015
Country 7649 0
Australia
Phone 7649 0
+61 2 9376 2251
Fax 7649 0
Email 7649 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.