The effectiveness of Transcranial Electro Stimulator Alternative - Hank Beckhoff (TESA-HB) in reducing the symptoms of Mild to Moderate Anxiety Episodes

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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.

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