Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000995774
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
6/09/2013
Date last updated
28/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Modulation of experimental pain using non-invasive brain stimulation.
Scientific title
The effect of transcranial direct current stimulation on sensitivity to experimental pain in healthy adults.
Secondary ID [1] 282979 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Experimental pain 289804 0
Condition category
Condition code
Neurological 290203 290203 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation
Dose: 2mA
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the dominant motor cortex using a direct current stimulator (Chattanooga Ionto, Tennessee, USA).
Intervention code [1] 287692 0
Treatment: Devices
Comparator / control treatment
Sham transcranial direct current stimulation
Dose: 2mA
Duration: The device is turned off slowly, out of the subject’s field of view, after 30 seconds of 2mA tDCS. The stimulating electrodes, however, remain on the stimulation site for a total of 30 minutes.
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day).
Control group
Placebo

Outcomes
Primary outcome [1] 290184 0
Sensitivity to electrical body pain stimuli: Electrical stimuli will be delivered to the subject's hand using a constant current stimulator. The subject will be asked to state when they can first ‘detect’ the electrical stimulus. The current intensity (mA) will be recorded. The electrical stimuli will be delivered until the subject can first confidently perceive the stimulus as being ‘painful.’ The current intensity (mA) will again be recorded. The trial will be repeated for a total of three times. The mean of 3 electrical ‘detection’ and ‘pain detection’ thresholds will be calculated.


Timepoint [1] 290184 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Primary outcome [2] 290417 0
Sensitivitiy to pressure body pain stimuli: Pressure stimuli will be delivered to the subject's hand using a pressure algometer. The pressure stimuli will be delivered until the subject can first confidently perceive the stimulus as being ‘painful.’ The pressure (kPa) will be recorded. The trial will be repeated for a total of three times. The mean of 3 ‘pain detection’ thresholds will be calculated.
Timepoint [2] 290417 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Primary outcome [3] 290418 0
Sensitivity to thermal body pain stimuli: For the cold pressor test, the subject’s hand will be immersed in ice saturated water (0-1 degrees celcius) to the wrist level, for a maximum of 2 min. The subject will first be asked to state when they can first confidently perceive the stimulus as being ‘painful.’ This time duration will be recorded. The subject will be instructed to withdraw the hand when they feel the pain as intolerable. This time duration will also be recorded. A single ‘pain detection’ threshold and ‘pain tolerance’ threshold will be calculated.

Timepoint [3] 290418 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Secondary outcome [1] 304069 0
Human salivary biomarker (e.g. BDNF) will be collected and measured using immuno-histo-chemical techniques.
Timepoint [1] 304069 0
The secondary outcome will be collected before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Secondary outcome [2] 304070 0
Perception of intensity of body pain stimuli using visual analogue scales.
Timepoint [2] 304070 0
The secondary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Secondary outcome [3] 304475 0
Perception of participant treatment awareness using visual analogue scales.
Timepoint [3] 304475 0
The secondary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.

Eligibility
Key inclusion criteria
Healthy
Both males and females
Aged 18-65
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Persistent neurological condition, current abuse of elicit substances and alcohol, pregnancy, does not understand English, magnetic/ metallic pieces inside skull, implanted metal devices (pacemaker, cochlear device, medication pumps, nervous system stimulators), cardiac disease, skin lesion near electrode sites, have ever experienced a convulsion or seizure.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on a power analysis (calculated by G*Power software) providing 80% power with one sided alpha =.05 and an effect size (f) of =.2 for the repeated measures study, and allowing for 25% dropout rate, we aim to recruit a total of 46 volunteers (i.e. 23 volunteers / group) for the study.


Tests conducted will be examined using a statistical software package (SPSS v. 20).

We aim to examine differences in detection and pain thresholds before and after the application of brain stimulation protocols and between treatment groups using paired t-tests and ANCOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2013
Actual
9/09/2013
Date of last participant enrolment
Anticipated
Actual
2/06/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
46
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7256 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 287754 0
University
Name [1] 287754 0
Bond University Higher Degree Student support scheme
Country [1] 287754 0
Australia
Primary sponsor type
University
Name
Bond University
Address
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country
Australia
Secondary sponsor category [1] 286476 0
None
Name [1] 286476 0
Address [1] 286476 0
Country [1] 286476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289699 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 289699 0
Ethics committee country [1] 289699 0
Australia
Date submitted for ethics approval [1] 289699 0
04/06/2013
Approval date [1] 289699 0
11/07/2013
Ethics approval number [1] 289699 0
RO1693

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42034 0
A/Prof Allan Abbott
Address 42034 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 42034 0
Australia
Phone 42034 0
+ 61 7 55954449
Fax 42034 0
Email 42034 0
[email protected]
Contact person for public queries
Name 42035 0
Brookes Folmli
Address 42035 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 42035 0
Australia
Phone 42035 0
+ 61 432102778
Fax 42035 0
Email 42035 0
[email protected]
Contact person for scientific queries
Name 42036 0
Allan Abbott
Address 42036 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 42036 0
Australia
Phone 42036 0
+61 7 55954449
Fax 42036 0
Email 42036 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.