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Trial registered on ANZCTR


Registration number
ACTRN12616001530415p
Ethics application status
Not yet submitted
Date submitted
1/11/2016
Date registered
7/11/2016
Date last updated
7/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Transcranial Electro Stimulator Alternative - Hank Beckhoff (TESA-HB) in reducing the symptoms of Mild to Moderate Anxiety Episodes
Scientific title
A controlled randomised study of TESA-HB for reducing the symptoms of Mild to Moderate Anxiety Episodes.
Secondary ID [1] 290212 0
Nil
Universal Trial Number (UTN)
U1111-1188-0136
Trial acronym
TESAAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 300386 0
Condition category
Condition code
Mental Health 300250 300250 0 0
Anxiety
Mental Health 300251 300251 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participant will attend the NZCIH clinic and complete the following in the order listed below on Day 1. The participant will be given the opportunity to ask questions as needed.
Informed Consent Form (signature required)
1. Hamilton Anxiety Rating Scale (HAM-A)
2. The Psychological General Well-Being Index (PGWB-S)-1
3. Hamilton Depression Rating Scale (HAM-D21)
4. Brief History Record
5. Medication Usage Log
6. Sleep Questionnaire

The participant will then undertake a one hour clinical assessment with the Research Clinical Psychologist whereby all assessment tools will be evaluated and the Clinical Psychologist determines the participant’s suitability for enrollment.

Treatment Days: 1-4 and 6-9

Within seven (7) days of enrolment participants will attend the clinic for treatment each day for ten (10) days (5 days on, 2 days off, 5 days on) for 50mins each session. Treatments will be conducted at the same time of day, throughout the Treatment Period. This is the same for all two Treatment Arms - device types: 15mA and placebo.

The TESA-HB is a Cranial Electrotherapy Stimulator (CES) device manufactured by Annecto Ltd. This device delivers a micro-current with a proprietary waveform for the treatment of anxiety, depression, and insomnia.

The TESA-HB Device delivers a modified bipolar high frequency (65-100kHz) low milliamp (15 mA) alternating current (AC) signal monopolar and bipolar modulated at 76-79Hz. During process of bipolar modulation polarity of waveform will be changed every 7 minutes.

The device delivers a current to electrodes that are placed sagitally on the participant’s skin behind each ear over the mastoid area, on neck and on the forehead.

Participants who do not complete, or are unable to complete, their entire two weeks of therapy, or who miss more than 2 treatment days will not be included in the per-protocol (PP) analysis. These participants will continue to be followed in the study, but will be classified in the intent-to-treat (ITT) group.

Intervention code [1] 295980 0
Treatment: Devices
Comparator / control treatment
All participants will be randomised to one of the two different arms, 50 participants in each group:
1. Treatment Arm A = 15mA TESA-HB Device
2. Treatment Arm B = Placebo Device
The front display of the arm B device will be absolutely identical to the front display of the arm A device and shows a digital read out of the treatment time. In contrast to the devices for arm A, devices for arm B will not deliver any current to participants. For both groups electrodes are applied to the skin surface: one to the forehead, one to neck and one behind each ear on the mastoid area. As there is no sensation by the electrodes the double blind method will not be compromised.
Control group
Placebo

Outcomes
Primary outcome [1] 299728 0
Change in the total score on the Hamilton Anxiety Rating Scale (HAM-A)
Timepoint [1] 299728 0
Baseline, Treatment days 5 and 10 and 12 weeks post last treatment session.
Secondary outcome [1] 327952 0
Change in the total score on the Hamilton Depression Rating Scale (HAM-D)
Timepoint [1] 327952 0
Baseline, treatment Day 10 and 12 weeks post last treatment session.
Secondary outcome [2] 327953 0
Change in total score on the Psychological General Well-Being Scale (PGWB-S)-1
Timepoint [2] 327953 0
Baseline, Treatment Day 5 and 10 and 8 and 12 weeks post last treatment session,
Secondary outcome [3] 327954 0
Change in hours of sleep assessed by a study-designed sleep questionnaire
Timepoint [3] 327954 0
Baseline, treatment days 1 - 10 and 2, 4, 8 and 12 weeks post last treatment.
Secondary outcome [4] 327955 0
Change in quality of sleep assessed by a study-designed questionnaire.
Timepoint [4] 327955 0
Baseline, treatment days 1 - 10 and 2, 4, 8 and 12 weeks post last treatment.

Eligibility
Key inclusion criteria
Diagnosed with a level of anxiety estimated from the Hamilton A (HAM-A) Rating Scale which categorises mild to moderate (18-24), or moderate to severe (25-30).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, taking prescription or natural antidepressants or psychotropic medications, sensitivity to electrodes and/or their conductive gels or adhesives, break in skin integrity at the areas of electrode placement, currently taking immune suppressing drugs or suspected use of narcotics, presence of any implanted electronic device, (cardiac stimulator or Pacemaker), history of brain injury (including seizures, epilepsy, stroke, tumour of central nervous system, or hydrocephalus), history of heart attacks, congestive heart failure, or uncontrolled hypertension, history of schizophrenia or manic depressive syndrome.

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)
On enrolment in the study a participant’s gender and HAM-A rating will be used as stratification variables for randomisation. A pre-computed randomisation table will be used to randomise. Since this is a double blinded study, the participant, the investigator, and other site personnel will not know which treatment will be received by the participant. All the TESA-HB devices will look identical, but each will be marked with a unique identification number. Only the Sponsor will know the unique numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A pre-computed randomisation table will be used to randomise.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Recruitment of 100 participants was based on a trial “Effects of music therapy on pain and anxiety in patients undergoing bone marrow biopsy and aspiration” whereby they evaluated the effectiveness of music therapy interventions on pain and anxiety control for 100 patients.

The HAM-A is scored independently based on a five-point, ratio scale. A rating of 0 indicates that the feeling is not present in the patient. A rating of 1 indicates mild prevalence of the feeling in the patient. A rating of 2 indicates moderate prevalence of the feeling in the patient. A rating of 3 indicates severe prevalence of the feeling in the patient. A rating of 4 indicates a very severe prevalence of the feeling in the patient. The Clinical Psychologist proceeds through the fourteen items, evaluating each criterion independently in form of the five-point scale described above. A total of the composite score based upon the summation of each of the 14 individually rated items will be completed. This calculation will yield a comprehensive score in the range of 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.

The Psychological General Well-being Index (PGWB-S) twenty-two items of the questionnaire will be analysed in a linear multiple regression model. A score transformation will be applied to convert the lowest and highest possible scores to 0 (worst possible level of well-being) and 110 (maximum level of well being), respectively.

The HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The sum of the scores from the first 17 items will apply within the following: 0-7 = Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, = 23 = Very Severe Depression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8260 0
New Zealand
State/province [1] 8260 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 294577 0
Commercial sector/Industry
Name [1] 294577 0
Annecto LLC
Address [1] 294577 0
252 West Swamp Road
Doylestown
Pennsylvania 18901
USA
Country [1] 294577 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Centre of Integrated Health
Address
Suite 6, Promed House
71 10th Avenue
Tauranga 3110
Country
New Zealand
Secondary sponsor category [1] 293445 0
Individual
Name [1] 293445 0
Dr Anna Rolleston
Address [1] 293445 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country [1] 293445 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296013 0
Health and Disability Ethics Committee
Ethics committee address [1] 296013 0
Ministry of Health
Ethics Department
Freyberg Building
Reception - Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 296013 0
New Zealand
Date submitted for ethics approval [1] 296013 0
14/11/2016
Approval date [1] 296013 0
Ethics approval number [1] 296013 0

Summary
Brief summary
Anxiety is a major health problem worldwide and the lifetime prevalence in New Zealand is approximately 25%. The key features of anxiety are uncontrollable, persistent and excessive nervousness and worry across specific or all settings, and relate to the anticipation of a future threat. The recent NZ Mental Health Survey, September 2016, showed mental disorder is common in New Zealand: 46.6% of the population are predicted to meet criteria for a disorder at some time in their lives, with 39.5% having already done so and 20.7% having a disorder in the past 12 months.
According to the Health Loss in New Zealand study, anxiety and depressive disorders are the second leading cause of health loss for New Zealanders, accounting for 5.3% of all health loss, behind only coronary heart disease (9.3%). Anxiety has detrimental effects, some lasting many years and left untreated, anxiety limits an individual’s daily functioning, often avoiding many aspects of life in an attempt to cope with, and relieve, the anxiety. Several medical devices using microcurrent levels of electrical stimulation have been approved for use in the area of anxiety, however the most effective waveform, current and application process, has not been determined.
The TESA-HB Device ANNECTO LLC is a transcranial electronic stimulation device delivers a modified bipolar high frequency low milliamp (15mA) alternating current (AC) modulated at 76-79Hz applied cranially through four external electrodes and is intended for the long-term reduction of pain. It is hypothesised that the TESA-HB Technology could also help to decrease depression, anxiety, and insomnia.

Researchers have noted that transcranial electronic stimulation applied within quasi resonance, resulted in stimulation and activation of the antinociceptive system with its endorphinergic and serotoninergic mechanisms.

The purpose of this work is to determine the effectiveness of the TESA-HB in reducing the symptoms of anxiety in people with mild to moderate episodes. The specific aims of the project are to determine the effect of 10 days of TESA-HB treatment on psychological general well-being, quality of sleep, quantity of sleep, quality of life, and anxiety score.
100 participants (18-65 years) will be recruited from the Tauranga area. The criteria for inclusion is a level of anxiety estimated from the Hamilton A (HAM-A) Rating Scale which categorises mild to moderate (18-24), or moderate to severe (25-30).
The participant will attend the NZCIH clinic and complete questionnaires on Day 1. The participant will be given the opportunity to ask questions as needed. The participant will then undertake a one hour clinical assessment with the Research Clinical Psychologist whereby all assessment tools will be evaluated and the Clinical Psychologist determines the participant’s suitability for enrolment.

Within seven (7) days of enrolment participants will attend the clinic for treatment each day for ten (10) days (5 days on, 2 days off, 5 days on) for 50mins each session. Treatments will be conducted at the same time of day, throughout the Treatment Period. This is the same for all two Treatment Arms - device types: 15mA and placebo.

The device delivers a current to electrodes that are placed sagitally on the participant’s skin behind each ear over the mastoid area, on neck and on the forehead.

Participants will return to the Clinic for follow up evaluations at 2 weeks, 4 weeks, 8 weeks and 12 weeks after completion of the last treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69262 0
Dr Anna Goodwin
Address 69262 0
New Zealand Centre of Integrated Health
Suite 6, Promed House
71 10th Avenue
Tauranga 3110
Country 69262 0
New Zealand
Phone 69262 0
+64275203112
Fax 69262 0
+6475795110
Email 69262 0
annag@braemarhospital.co.nz
Contact person for public queries
Name 69263 0
Ms Desiree De Spong
Address 69263 0
New Zealand Centre of Integrated Health
Suite 6, Promed House
71 10th Avenue
Tauranga 3110
Country 69263 0
New Zealand
Phone 69263 0
+64275443424
Fax 69263 0
+6475795510
Email 69263 0
desiree@aetiology.co.nz
Contact person for scientific queries
Name 69264 0
Dr Anna Rolleston
Address 69264 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country 69264 0
New Zealand
Phone 69264 0
+6475786624
Fax 69264 0
Email 69264 0
anna@thecardiacclinic.co.nz

No information has been provided regarding IPD availability
Summary results
No Results