Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000071224
Ethics application status
Approved
Date submitted
15/01/2009
Date registered
28/01/2009
Date last updated
14/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain stimulation to reduce pain following spinal cord injury
Scientific title
Treatment of neuropathic pain following spinal cord injury using transcranial direct current stimulation
Secondary ID [1] 252916 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic spinal cord injury pain 4194 0
Condition category
Condition code
Neurological 4403 4403 0 0
Other neurological disorders
Anaesthesiology 4404 4404 0 0
Pain management
Injuries and Accidents 4405 4405 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anodal and cathodal transcranial direct current stimulation (tDCS) of primary motor cortex using a saline-soaked pair of surface sponge electrodes at constant current intensity of 2 milliamps for 20 minutes administered daily during 2 x 5 day periods separated by 4 weeks without treatment. The site of electrode placement will be determined using a standard Electroencephalography (EEG) head cap used to position EEG recording electrodes. The anode electrode will be placed over C3 or C4 (using EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (i.e. above the opposite eye socket).

Magnetic resonance imaging (MRI) pre- and post-treatment to investigate brain alterations associated with reduction in pain intensity using tDCS. Functional MRI (fMRI) and structural imaging performed prior to and immediately following each treatment week and at 10 weeks and 6 months follow-up after study commencement.
Intervention code [1] 3911 0
Treatment: Devices
Comparator / control treatment
Control (sham) stimulation in which transcranial direct current stimulation will be delivered for 30 seconds using surface sponge electrodes placed in the same positions as for active stimulation and then discontinued for the remainder of the 20 minute treatment session. All subjects will receive both real and sham stimulation, each comprising 5 daily sessions with a "washout" period of 4 weeks between them (i.e. all subjects will receive the active treatment in one 5 day treatment period and the placebo treatment in the other 5 day treatment period).
Control group
Placebo

Outcomes
Primary outcome [1] 5290 0
Pain severity as assessed by administration of the International Spinal Cord Injury Basic Pain Dataset and/or Neuropathic Pain Scale
Timepoint [1] 5290 0
At baseline, prior to and after each period of intervention, days 1-5 of each treatment week and at 10 weeks and 6 months after intervention commencement
Secondary outcome [1] 8898 0
Functional independence as assessed by administration of the Spinal Cord Independence Measure (SCIM III)
Timepoint [1] 8898 0
At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement
Secondary outcome [2] 8899 0
Mood as assessed by administration of the Beck Depression Inventory
Timepoint [2] 8899 0
At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement
Secondary outcome [3] 8900 0
Patient global impression of change (PGIC)
Timepoint [3] 8900 0
At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement
Secondary outcome [4] 266021 0
Measurements of brain changes using MRI techniques
Timepoint [4] 266021 0
At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Complete thoracic spinal cord injury (American Spinal Injury Association (ASIA) Impairment Scale (AIS) A)
6 or more months following injury
Medically stable
Persistent neuropathic pain present for more than 6 months which is moderate to severe in intensity (greater than or equal to 4/10 on a numerical rating scale)
Must give informed consent to participate in the study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual or mental impairment preventing full understanding of the risks and benefits of participating and/or obtaining informed consent
Subjects who have metal objects in their body, anxiety disorders, such as claustrophobia, panic attacks or any psychiatric disorder may be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2010
Actual
2/07/2010
Date of last participant enrolment
Anticipated
Actual
18/06/2012
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] 4375 0
Government body
Name [1] 4375 0
NSW Office for Science and Medical Research
Country [1] 4375 0
Australia
Primary sponsor type
Individual
Name
Prof Philip Siddall
Address
Pain Management Research Institute
Level 10 Main Block
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 3939 0
Individual
Name [1] 3939 0
Dr Paul Wrigley
Address [1] 3939 0
Pain Management Research Institute
Level 13 Kolling Building
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country [1] 3939 0
Australia
Other collaborator category [1] 251609 0
Individual
Name [1] 251609 0
Dr Sylvia Gustin
Address [1] 251609 0
Pain Management Research Institute
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country [1] 251609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6424 0
Northern Sydney Central Coast Health Human Research Ethics Committee
Ethics committee address [1] 6424 0
Research Office
Level 2 Building 51
Royal North Shore Hospital
Pacific Hwy St Leonards NSW 2065
Ethics committee country [1] 6424 0
Australia
Date submitted for ethics approval [1] 6424 0
16/10/2008
Approval date [1] 6424 0
18/03/2009
Ethics approval number [1] 6424 0
0811-241M(CTN-dev)

Summary
Brief summary
Pain, particularly neuropathic pain, is a common and debilitating consequence of spinal cord injury. Despite the high prevalence and severity of pain, there are currently no available treatments that provide consistent or satisfactory relief. Transcranial direct current stimulation (tDCS) is a safe non-invasive brain stimulation technique that may be helpful in reducing pain following spinal cord injury. This study is aimed at evaluating the effectiveness of tDCS as a treatment for spinal cord injury neuropathic pain. Subjects will undergo 10 tDCS treatment sessions over a period of 5 weeks as well as magnetic resonance imaging (MRI) scans prior to and immediately following each treatment week, and at 10 weeks and 6 months after study commencement. The technique is not painful and no serious side effects have been reported. Our hypothesis is that tDCS will provide relief of neuropathic pain following spinal cord injury. If proven effective, tDCS may provide a much needed non-invasive alternative treatment for patients with persistent spinal cord injury neuropathic pain.
Trial website
Trial related presentations / publications
Wrigley PJ, Gustin SM, McIndoe LN, Chakiath RJ, Henderson LA, Siddall PJ. Longstanding neuropathic pain after spinal cord injury is refractory to transcranial direct current stimulation: a randomized controlled trial. Pain. 2013 Oct;154(10):2178-84.
Public notes

Contacts
Principal investigator
Name 35087 0
Prof Philip Siddall
Address 35087 0
Pain Management Service, Hammondcare
Greenwich Hospital, River Road, Greenwich, NSW, 2065, Australia
Country 35087 0
Australia
Phone 35087 0
+ 61 2 8788 3941
Fax 35087 0
Email 35087 0
psiddall@hammond.com.au
Contact person for public queries
Name 12434 0
Dr Dr Paul Wrigley
Address 12434 0
Pain Management Research Institute
Level 13 Kolling Building
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country 12434 0
Australia
Phone 12434 0
+61 2 99264958
Fax 12434 0
Email 12434 0
paul.wrigley@sydney.edu.au
Contact person for scientific queries
Name 3362 0
Prof Prof Philip Siddall
Address 3362 0
Pain Management Research Institute
Level 10 Main Block
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country 3362 0
Australia
Phone 3362 0
+61 2 99266387
Fax 3362 0
Email 3362 0
phil.siddall@sydney.edu.au

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

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