2.1 Alpha‑Stim AID is an electrotherapy device that uses a variable electric microcurrent to stimulate alpha wave activity. The current has a pulse repetition rate of 0.5 hertz, with a pattern of bipolar asymmetric rectangular waves which repeat at 10‑second intervals.
2.2 Alpha‑Stim AID is compact, about the size of a mobile phone, and delivers an electric current through a pair of small clips attached to the ear lobes. The clips have removable soft pads that are moistened to ensure electricity conduction. The strength of the current can be adjusted. Alpha‑Stim AID is recommended to be used for between 20 and 60 minutes every day, every other day or as needed to treat symptoms of anxiety. Alpha‑Stim AID is battery powered and portable. The company has 7 previous versions of the Alpha‑Stim AID device and states that all versions are based on the same mechanism of action.
2.3 Alpha‑Stim AID differs from other anxiety disorder treatments because it uses a patented electrical wave pattern that is transmitted to the brain to stimulate the production of alpha waves.
2.4 Alpha‑Stim AID is intended to be used to treat anxiety, insomnia and depression. This guidance focuses on the use of Alpha‑Stim AID for treating anxiety disorders. The device can be self-administered at home, or by a healthcare professional in a hospital or clinic. Alpha‑Stim AID may affect the functioning of implanted cardiac pacemakers and defibrillators. The instructions for use note that people should not operate potentially dangerous machinery or vehicles during treatment, and sometimes for several hours after treatment. The safety of cranial electrotherapy has not been established during pregnancy. The device has a 5‑year warranty.
2.5 NICE's guideline on generalised anxiety disorder and panic disorder in adults: management provides principles of care for people with generalised anxiety disorder. It recommends a stepped‑care model to organise service provision and to help people with generalised anxiety disorder, their families, carers and practitioners choose the most effective intervention.
2.6 Improving Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies to people with anxiety disorders and depression. A clinical expert noted that IAPT teams are the standard structure of service provision for people with anxiety and depression in most regions of England. IAPT teams deliver the NICE-recommended stepped-care model for generalised anxiety disorder.
2.7 NICE's guideline on social anxiety disorder: recognition, assessment and treatment provides treatment principles for adults with social anxiety disorder. It recommends the use of individual cognitive behavioural therapy (CBT). If a person wants to have drug treatment, a selective serotonin reuptake inhibitor (escitalopram or sertraline) should be offered. For adults who decline CBT and drug treatment, short-term psychodynamic psychotherapy, that has been specifically developed to treat social anxiety disorder, should be considered.
2.8 The cost of Alpha‑Stim AID is £450 (excluding VAT) per device. The device can be reused by multiple people. A per-person treatment cost of £70 is used in the cost modelling, which is based on a treatment time of 10 weeks and includes £40 to cover other costs such as staff time, postage and consumables.
For more details, see the Alpha-Stim website for Alpha-Stim AID for anxiety disorders.