Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000366954
Ethics application status
Approved
Date submitted
6/04/2011
Date registered
11/04/2011
Date last updated
2/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a very short Wi-Fi pulse on brain activity in healthy volunteers: fMRI double blind randomized study.
Scientific title
Effect of a single, REAC pulse on brain activity in healthy volunteers: fMRI double blind randomized pilot study.
Secondary ID [1] 259943 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
fMRINPOREAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Studies of the normal brain and nervous system 265561 0
Condition category
Condition code
Neurological 265708 265708 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 265709 265709 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study to examine with functional magnetic resonance imaging (fMRI) the effects on brain activity of voluntary healthy subjects, following a single, very low power 250 ms transcutaneous radio electric asymmetric conveyer pulse applied via electrode placed on the ear pavillion for 500 ms.
Intervention code [1] 264354 0
Treatment: Devices
Comparator / control treatment
Placebo. Placebo treatment, is the same device was applied to those in treated group, but with the REAC field turned off. Placebo pulse applied via electrode placed on the ear pavillion for 500 ms.
Control group
Placebo

Outcomes
Primary outcome [1] 266474 0
Assess if the REAC pulse, well below the temporal resolution of fMRI, might show some effect on the brain. This outcome is assessed with fMRI examination.
Timepoint [1] 266474 0
After administering either the REAC pulse or the placebo treatment, all subjects were brought back to the magnet room to repeat an fMRI examination.
Secondary outcome [1] 273848 0
Assess if the REAC pulse, well below the temporal resolution of fMRI, might show some effect on cerebellum activity. This outcome is assessed with fMRI examination.
Timepoint [1] 273848 0
After administering either the REAC pulse or the placebo treatment, all subjects were brought back to the magnet room to repeat an fMRI examination.

Eligibility
Key inclusion criteria
healthy subjects
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no healthy people

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)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3343 0
Italy
State/province [1] 3343 0

Funding & Sponsors
Funding source category [1] 264822 0
University
Name [1] 264822 0
Istituto di Radiologia, Universita degli Studi di Cagliari
Country [1] 264822 0
Italy
Primary sponsor type
University
Name
Istituto di Radiologia, Universita degli Studi di Cagliari
Address
Universita Degli Studi di Cagliari Policlinico Universitario
Strada Statale 554, KM. 4.500
postcode: 09042
Monserrato (CA)
Country
Italy
Secondary sponsor category [1] 263930 0
Other Collaborative groups
Name [1] 263930 0
Istituto Rinaldi Fontani
Address [1] 263930 0
Istituto Rinaldi Fontani
Viale Belfiore 43
50144 Firenze
Country [1] 263930 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266788 0
COMITATO ETICO DELL'AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Ethics committee address [1] 266788 0
Ethics committee country [1] 266788 0
Italy
Date submitted for ethics approval [1] 266788 0
Approval date [1] 266788 0
18/07/2008
Ethics approval number [1] 266788 0
IRB00007667

Summary
Brief summary
Background: Electromagnetic brain stimulation techniques have been used to map brain areas, to treat psychiatric disorders such as depression and rehabilitation. Often to see the changes of activation or inhibition of brain areas or to assess any change in synaptic plasticity induced by these stimuli, functional magnetic resonance imaging (fMRI) is used.
Methods This double blind randomized pilot study, is the first study to examine with functional magnetic resonance imaging (fMRI) the effects on brain activity of voluntary healthy subjects, following a single, very low power 250 ms transcutaneous radio electric asymmetric conveyer (REAC) pulse. The primary target of this study was to assess if the REAC pulse, well below the temporal resolution of fMRI, might show some effect on the brain and particularly on cerebellum activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32447 0
Address 32447 0
Country 32447 0
Phone 32447 0
Fax 32447 0
Email 32447 0
Contact person for public queries
Name 15694 0
Salvatore Rinaldi
Address 15694 0
Istituto Rinaldi Fontani
Viale Belfiore 43
50144 Firenze
Country 15694 0
Italy
Phone 15694 0
+39 055 290307
Fax 15694 0
Email 15694 0
[email protected]
Contact person for scientific queries
Name 6622 0
Salvatore Rinaldi
Address 6622 0
Istituto Rinaldi Fontani
Viale Belfiore 43
50144 Firenze
Country 6622 0
Italy
Phone 6622 0
+39 055 290307
Fax 6622 0
Email 6622 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
SourceTitleYear of PublicationDOI
Dimensions AILong-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study2014https://doi.org/10.1038/srep05668
Dimensions AIPreliminary pilot fMRI study of neuropostural optimization with a noninvasive asymmetric radioelectric brain stimulation protocol in functional dysmetria2012https://doi.org/10.2147/ndt.s29971
N.B. These documents automatically identified may not have been verified by the study sponsor.