Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000263796
Ethics application status
Approved
Date submitted
2/12/2021
Date registered
14/02/2022
Date last updated
31/01/2023
Date data sharing statement initially provided
14/02/2022
Date results information initially provided
31/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of superficial wireless neuromodulation in healthy adults.
Scientific title
Effects of superficial wireless neuromodulation on wellness in healthy adults
Secondary ID [1] 305759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 324263 0
insomnia 324562 0
Condition category
Condition code
Mental Health 321760 321760 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Superficial Wireless Neuromodulation is a technique based on Bluetooth technology that consists of 4 wireless devices that are placed in the distal third of each of the extremities, controlled by an integrated application through a smartphone. This device emits biphasic and monophasic rectangular galvanic electrical impulses of very low frequency (0.5-14Hz) coordinated through 28 electrodes distributed between feet and hands (gloves and anklets).

Patients will receive 2 sessions of Superficial Wireless Neuromodulation, 60 minutes each session, held one week apart. The principal investigator and a trained researcher will apply the protocol and will register the attendance.
Intervention code [1] 322354 0
Treatment: Devices
Comparator / control treatment
Patients will receive 2 sessions of superficial wireless neuromodulation with devices turned off.
Control group
Placebo

Outcomes
Primary outcome [1] 329785 0
Wellness: a wellness survey created by the researchers.
Timepoint [1] 329785 0
1 month after the last treatment session
Secondary outcome [1] 403757 0
Quality of Life: European Quality of Life-5 Dimensions (EQ-5D) questionnaire
Timepoint [1] 403757 0
1 month after the last treatment session
Secondary outcome [2] 403758 0
General Health: 36-item short form health survey (SF-36)
Timepoint [2] 403758 0
1 month after the last treatment session

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation concealment will be performed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation wil be performed using dice-rolling
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
20/02/2022
Actual
21/02/2022
Date of last participant enrolment
Anticipated
Actual
25/02/2022
Date of last data collection
Anticipated
Actual
13/05/2022
Sample size
Target
40
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 24368 0
Spain
State/province [1] 24368 0
Gipuzkoa

Funding & Sponsors
Funding source category [1] 310119 0
University
Name [1] 310119 0
University Of Deusto
Country [1] 310119 0
Spain
Primary sponsor type
University
Name
University of Deusto
Address
Mundaiz 50, Donostia - San Sebastián 20012
Country
Spain
Secondary sponsor category [1] 311186 0
None
Name [1] 311186 0
Address [1] 311186 0
Country [1] 311186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309808 0
Comité de Ética en Investigación de la Universidad de Deusto
Ethics committee address [1] 309808 0
Mundaitz Kalea, 50, 20012 Donostia, Gipuzkoa
Ethics committee country [1] 309808 0
Spain
Date submitted for ethics approval [1] 309808 0
15/02/2022
Approval date [1] 309808 0
09/02/2022
Ethics approval number [1] 309808 0

Summary
Brief summary
The aim of this study is to assess the effects of the wireless superficial neuromodulation in quality of life and wellness or healthy people. Two sessions of 60 minutes duration will be applied and patients will fill general health, quality of life and wellness surveys before and 1 month after the intervention.
We hypothesize that general health, quality of life and wellness levels will improve after treatment.
Trial website
Trial related presentations / publications
Public notes
These phone numbers are general ones. To contact specifically with the researches, this information should be taken on count:
- Iker Villanueva Ruiz: 5375 extension should be used.
- Ane Arbillaga Etxarri: 5266 extension should be used.

Contacts
Principal investigator
Name 115458 0
Dr Ane Arbillaga Etxarri
Address 115458 0
University of Deusto San Sebastian, Mundaitz Kalea, 50, 20012 Donostia, Gipuzkoa
Country 115458 0
Spain
Phone 115458 0
+34 943 32 66 00
Fax 115458 0
Email 115458 0
ane.arbillaga@deusto.es
Contact person for public queries
Name 115459 0
Mr Iker Villanueva Ruiz
Address 115459 0
University of Deusto San Sebastian, Mundaitz Kalea, 50, 20012 Donostia, Gipuzkoa
Country 115459 0
Spain
Phone 115459 0
+34 943 32 66 00
Fax 115459 0
Email 115459 0
iker.villanueva@deusto.es
Contact person for scientific queries
Name 115460 0
Mr Iker Villanueva Ruiz
Address 115460 0
University of Deusto San Sebastian, Mundaitz Kalea, 50, 20012 Donostia, Gipuzkoa
Country 115460 0
Spain
Phone 115460 0
+0034 943 32 66 00
Fax 115460 0
Email 115460 0
iker.villanueva@deusto.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data protection law does not allow


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.