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Trial registered on ANZCTR


Registration number
ACTRN12619000312145p
Ethics application status
Not yet submitted
Date submitted
21/02/2019
Date registered
28/02/2019
Date last updated
28/02/2019
Date data sharing statement initially provided
28/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effect ear lobe stimulation on mental health
Scientific title
Heart rate variability changes following transcutaneous vagal nerve stimlulation at the ear in adult patients with a history of mental illness
Secondary ID [1] 297478 0
None
Universal Trial Number (UTN)
U1111-1229-0368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311668 0
Anxiety 311669 0
Post Traumatic Stress Disorder 311670 0
Obsessive Compulsive Disorder 311671 0
Complex Trauma 311672 0
Personality Disorders 311673 0
Condition category
Condition code
Mental Health 310293 310293 0 0
Anxiety
Mental Health 310294 310294 0 0
Depression
Mental Health 310295 310295 0 0
Psychosis and personality disorders
Mental Health 310319 310319 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The VNS Therapy Aspire HC Pulse Generator Model 105 is approved by the TGA for vagal transcutaneous nerve stimulation (VNS). The current study uses a dose of 1.25-1.5 mA; 250 microsec applied under the pain threshold to the ear or at the neck by the clinical scientist who has experience in biosignal processing. Intervention is twice per week at the clinic when participants attend for their therapy over a four week period as recommended by distributor and scientific literature.Physiological response to VNS will be measured with a Thought Technology Infinity 5 system that measures heart rate, respiratory rate, skin conductance, EMG and temperature. Measures will be undertaken prior to commencing with intervention and post 4 weeks of intervention. These physiological responses will also be recorded during each session. In addition the Beck Depression questionnaire and general anxiety questionnaire as well as the PCL 5 will be included to assess psychological benefits. EEG will be used to determine any changes in brain networks using the EEGer V4 system with electrodes placed at Fz, Cz, Pz, F2, F3, T3 and T4. There are two groups of participants recruited (power analysis for a two group comparative design requires 41 participants in each group) to be confident that a difference between the two groups can be observed if present. The VNS group will receive VNS as part of the biofeedback intervention, whereas the control group will receive biofeedback through either heart rate variability or EMG feedback, which constitutes treatment as usual. HRV and EMG biofeedback combined with diaphragmatic breathing also affects vagal nerve function and improves mental health. Diaphragmatic breathing requires breathing cycles of 10 sec, breathing in through the nose and out through the mouth. Participants are instructed to allow the abdomen to exand rather than the chest when breathing. Both groups will be required to undertake diaphragmatic breathing twice per day as home practice for 10 to 20 minutes each time during the trial. Adherence wil lbe recorded by a home diary. Each session at the clinic will be approximately 45 minutes, constituting participant review and up to 30 minutes of either heart rate or EMG biofeedback or vagal nerve stimulation depending on which group the participant was randomly selected to.
Intervention code [1] 313730 0
Treatment: Devices
Comparator / control treatment
The control group will receive biofeedback (EMG or HRV) as treatment per usual over the 4 week period, twice per week and attend for 45 minutes each session. Identical recordings are made of the control group physiological parameters including heart rate, EMG, skin conductance and temperature to assess efficacy of treatment and compare to the VNS group. In addition the Beck Depression questionnaire and general anxiety questionnaire as well as the PCL 5 will be included to assess psychological benefits. EEG will be used to determine any changes in brain networks using the EEGer V4 system with electrodes placed at Fz, Cz, Pz, F2, F3, T3 and T4. 41 participants will be included to allow for sufficient power to determine any differences to the intervention group if significant differences exist
Control group
Active

Outcomes
Primary outcome [1] 319184 0
Heart rate variability % change using Kubios analysis software. Physiological variables are recorded using Thought Technology Infinity 5 hardware and software
Timepoint [1] 319184 0
Heart rate variability is measured as change in very low power, low power and high power of the heart rate signal, which is decomposed using a Fast Fourier algorithm. Results are compared between the first session and following last session at 4 weeks for the control group receiving treatment as usual (EMG / HRV biofeedback) and the VNS group.
Primary outcome [2] 319185 0
Mean score for Beck depression questionnaire
Timepoint [2] 319185 0
Change in mean scores between prior to first session and following last session at 4 weeks for the control group receiving treatment as usual (EMG / HRV biofeedback) and the VNS group.
Primary outcome [3] 319186 0
EEG wave amplitudes for delta, theta, alpha and beta waves at F2, F3, T3, T4, Fz, Cz and Pz using EEGer software and hardware is used to assess change in neurophysiological brain activity
Timepoint [3] 319186 0
Change in mean scores between prior to first session and following last session at 4 weeks for the control group receiving treatment as usual (EMG / HRV biofeedback) and the VNS group.
Secondary outcome [1] 367230 0
Change in mean scores for the GAD
Timepoint [1] 367230 0
Change in GAD mean scores comparing results prior to first session and then on weekly intervals for the control group receiving treatment as usual (EMG / HRV biofeedback) and the VNS group.
Secondary outcome [2] 367271 0
Mean change in PCL5 scores for depression and anxiety
Timepoint [2] 367271 0
Measures to be undertaken prior to first session and following 4 weeks of intervention

Eligibility
Key inclusion criteria
Age greater than 18 years of age, presenting as patient at psychiatric clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with Alzheimer's disease or Parkinson's disease as well as severe psychosis will 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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G*Power was used to calculate the number of participants required if an effect size of 0.8 is expected with power of 0.95 and a p value of 0.05. The number of participants required are 41 per group.
Students t-test for comparing means between the two groups will be used for statistical analysis unless the group data is not normally distributed in which case the Mann Whitney test will be applied

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
20/10/2019
Actual
Date of last data collection
Anticipated
20/10/2019
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302046 0
University
Name [1] 302046 0
Charles Sturt University
Country [1] 302046 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Thurgoona Dr
Albury
NSW, 2640
Country
Australia
Secondary sponsor category [1] 301855 0
Commercial sector/Industry
Name [1] 301855 0
ZenWaves Clinic
Address [1] 301855 0
11/15-17 Kildare Rd, Blacktown NSW 2148
Country [1] 301855 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302728 0
Charles Sturt Human Ethics Research Committee
Ethics committee address [1] 302728 0
Ethics committee country [1] 302728 0
Australia
Date submitted for ethics approval [1] 302728 0
01/03/2019
Approval date [1] 302728 0
Ethics approval number [1] 302728 0

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

Contacts
Principal investigator
Name 91182 0
A/Prof Herbert Jelinek
Address 91182 0
School of Community Health
Charles Sturt University
Thurgoona Drive
Albury
NSW2640
Country 91182 0
Australia
Phone 91182 0
+61260519219
Fax 91182 0
Email 91182 0
hjelinek@csu.edu.au
Contact person for public queries
Name 91183 0
Herbert Jelinek
Address 91183 0
School of Community Health
Charles Sturt University
Thuhrgoona Drive
Albury
NSW2640
Country 91183 0
Australia
Phone 91183 0
+61260519219
Fax 91183 0
Email 91183 0
hjelinek@csu.edu.au
Contact person for scientific queries
Name 91184 0
Herbert Jelinek
Address 91184 0
School of Community Health
Charles Sturt University
Thurgoona Drive
Albury
NSW2640
Country 91184 0
Australia
Phone 91184 0
+61427681754
Fax 91184 0
Email 91184 0
ubik2011@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Physiological variables recorded including heart rate, blood pressure, skin conductance, EMG and temperature.
EEG data as amplitudes associated with delta, theta, alpha and beta rhythms
Questionnaire data.
All data will be de-identified prior to making data available on request
When will data be available (start and end dates)?
Data is available from the conclusion of study approximately December 2019, no end date
Available to whom?
on request to recognised researchers with expertise in this area of study
Available for what types of analyses?
further statistical and data mining analysis
How or where can data be obtained?
Spreadsheet


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.