Alpha-Stim AID for anxiety disorders

The committee considered that Alpha‑Stim AID's mode of action was uncertain although the clinical experts explained the physiological role of alpha brain waves in mediating feelings of calmness. The clinical experts and the external assessment centre (EAC) reviewed the evidence submitted at consultation. They concluded that there was no robust evidence showing the effect of regular use of Alpha‑Stim AID on the brain waves of people with anxiety disorders. The committee considered that a clear understanding of the therapeutic effect of this technology is important. It proposed that further evidence is generated to investigate any acute or longer-term changes in brain activity after using Alpha‑Stim AID in people with anxiety disorders. Potential studies could involve using a sham device as a control and recording brain activity, for example by electroencephalography or functional imaging.

The randomised controlled trial evidence showed short-term relief of anxiety symptoms with Alpha‑Stim AID in people with anxiety disorders. However, the committee noted that the quality of the evidence was low because of a high risk of bias. The committee was concerned about the possibility of a significant placebo effect with Alpha‑Stim AID. But it also acknowledged that reducing anxiety symptoms was the most important outcome regardless of how this was achieved. The committee concluded that a well-planned and well-conducted trial is needed to be certain about Alpha‑Stim AID's clinical benefit.

The evidence consisted of relatively short-term studies, mostly with follow-up periods of 6 to 12 weeks. In 1 study follow up was 24 weeks. The clinical experts advised that anxiety disorders are long-term conditions and many people have relapses in symptoms. No convincing evidence was available on the longer-term benefits of Alpha‑Stim AID and the committee concluded that further research was needed to explore this.

The clinical experts explained that there are several different treatments offered to people with anxiety disorders in the NHS. The committee considered that Morriss et al. (2019) provided information about the use of Alpha‑Stim AID in people waiting for individual cognitive behavioural therapy (CBT). But aside from this, there is a lack of evidence to support the use of Alpha‑Stim AID at specific points in the pathway. Also, there is uncertainty about how the clinical effect of Alpha‑Stim AID compares with other treatments. The committee noted, for example, that there was no evidence for the effect of Alpha‑Stim AID compared with medication in people with anxiety disorders. It recognised that Alpha‑Stim AID may not replace other options in the treatment pathway, but it could be an additional option (see section 4.7 and section 4.8). The committee proposed that further evidence would be helpful to understand Alpha‑Stim AID's benefit compared with established treatments for anxiety disorders, such as individual CBT or medication, or both.

The evidence suggested that adverse events with Alpha‑Stim AID were mild. The clinical experts explained that people may have vertigo or dizziness when Alpha‑Stim AID is first used, particularly at a high electric current, but these symptoms tend to lessen when the current is reduced. Data from the patient survey confirmed that the device is generally well tolerated. The committee concluded that people using Alpha‑Stim AID have a low risk of side effects. Also, the device might be a treatment option for some people for whom conventional treatments are unsuitable or who would prefer to avoid them.

The clinical experts advised that training on the correct use of Alpha‑Stim AID is important and this is offered to people before treatment starts. This involves explaining technical issues such as ensuring correct connections and setting appropriate currents. The patient expert also noted that people may need ongoing support while using Alpha‑Stim AID at home. The committee concluded that providing information and support was essential to ensure that the technology is used correctly.

The clinical experts explained that because of the number of people with anxiety disorders there is huge pressure on individual CBT services. They also explained that individual CBT is not suitable for everyone and some people may have to wait a long time to have it. So, easy access to self-administered treatment such as Alpha‑Stim AID that can be used at home is a potentially attractive option for people waiting for individual CBT. The committee also considered that a range of different options for anxiety disorders was needed in the NHS so that treatment can be tailored to the person's needs. The clinical experts explained that Alpha‑Stim AID can be offered early in the care pathway (see section 4.8) and it may help people engage better with subsequent individual CBT if it is still needed. The clinical experts also suggested that Alpha‑Stim AID may particularly benefit people who want to avoid taking medication or when medication is unsuitable for them. The committee understood the importance of choice in treating anxiety in primary care and that this technology could be used to complement existing treatments for anxiety disorders. It concluded that Alpha‑Stim AID has the potential to be a useful addition to the care pathway if evidence showing its clinical benefits is generated (see sections 4.2 to 4.4).

The clinical experts explained about the potential role of Alpha‑Stim AID in primary care, where there is an unmet clinical need for people with anxiety disorders. The committee noted that the EAC has reviewed the results of a study exploring the use of Alpha‑Stim AID as a first‑line treatment for anxiety in primary care. A clinical expert who is a GP described the use of Alpha‑Stim AID within social prescribing in his practice. Initial results suggested that uptake of Alpha‑Stim AID and feedback from people using it was good. The clinical experts advised that people who do not want to have medication or psychological therapy often prefer to use Alpha‑Stim AID. The committee concluded that Alpha‑Stim AID may fit better in primary care where a range of treatment options is needed and this should be explored in further studies.

The committee considered that the Improving Access to Psychological Therapies (IAPT) model reflects current care but there was limited data available to populate the uptake and response rates in this complex pathway. The primary care model reflected an alternative position for the technology in the care pathway, but the committee again noted that limited data was available to populate the model. So, it was difficult to draw firm conclusions from either model about the cost benefits of using Alpha‑Stim AID. The committee concluded that further clinical efficacy evidence was needed to accurately assess whether using Alpha‑Stim AID alone or as an add-on treatment would lead to cost savings compared with standard care.

In the EAC's base-case analysis for the IAPT model, the main drivers in the cost model were the uptake rate and response rates for the different treatments. The clinical experts explained that the uptake rates were likely to vary across services and people's preferences. They considered that the uptake rate of 22% used in the EAC's model did not reflect the much higher rates found in their own clinical practice. The clinical experts also commented that people may stop treatment early with Alpha‑Stim AID if their symptoms improved and this may have confounded the calculated response rates. The committee concluded that more robust data was needed to understand the potential resource impact of using Alpha‑Stim AID in the NHS.

The committee noted the mostly positive patient experience described in the response to the patient survey and in patients' consultation comments. It considered that Alpha‑Stim AID shows significant promise for managing anxiety disorders, but further studies are needed to address uncertainties about its clinical efficacy. A fundamental understanding of the effect of Alpha‑Stim AID on brain function in people with anxiety disorders would be helpful. For example, from a study using electroencephalography or functional imaging in treatment and sham groups. The committee considered that a well-conducted randomised controlled trial should be done to evaluate the short- and long-term effects of Alpha‑Stim AID compared with established treatment options such as medication and individual CBT. Such a study should include an assessment of patient-reported outcome measures and resource use to inform a future assessment of the cost consequence of using Alpha‑Stim AID in the NHS.

The committee considered that collecting real‑world data on the use of Alpha‑Stim AID would be helpful to understand issues in different clinical scenarios, such as:

• people's treatment preferences

• the uptake of the device and

• the response rates and treatment completion rates.