4 Committee discussion

Clinical-effectiveness overview

A better understanding of how Alpha-Stim AID works in people with anxiety disorders is needed

4.1 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 confirmed that Alpha-Stim AID's mode of action had not been investigated in people with anxiety disorders. The committee was therefore concerned about the plausibility of its therapeutic effect. It proposed that further studies should be done, for example using electroencephalography, to record any acute or longer-term changes in brain waves after using Alpha-Stim AID in people with anxiety disorders.

Alpha-Stim AID is a treatment option for managing anxiety disorders, but the evidence is weak

4.2 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 well planned and well-conducted trials were needed to be certain about Alpha-Stim AID's clinical benefit.

Evidence on the long-term benefit of using Alpha-Stim AID is needed

4.3 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.

More evidence is needed to assess the effect of Alpha-Stim AID compared with other options in the care pathway

4.4 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 iCBT. But aside from this, the evidence about the effect of different treatments or treatment combinations was uncertain. The committee noted, for example, that there was no evidence comparing the effect of Alpha-Stim AID with medication in people with anxiety disorders. It concluded that there was significant uncertainty about the possible role of Alpha-Stim AID in a complex mental health care pathway. The committee proposed that further studies were needed to compare Alpha-Stim AID with established treatments for anxiety disorders, such as iCBT and medication.

Side effects and adverse events

Alpha-Stim AID is a low-risk device with no serious side effects

4.5 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.

NHS considerations overview

Training and ongoing support is important for people using Alpha-Stim AID at home

4.6 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 position of Alpha-Stim AID in the treatment pathway is not clear

4.7 The clinical experts explained that because of the number of people with anxiety disorders there is huge pressure on iCBT services. They also explained that iCBT is not suitable for everyone and some people may have to wait for quite some 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 iCBT. The committee also considered that a range of different options was needed in the NHS so that treatment for anxiety disorders can be tailored to the needs of individual people. The clinical experts explained that Alpha-Stim AID can be offered early in the care pathway and it may help people engage better with subsequent iCBT if this 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 concluded that although there is demand for a range of treatment options for managing anxiety disorders, the clinical benefits of Alpha-Stim AID in the care pathway remained uncertain (see sections 4.2 to 4.4).

There is potential for Alpha-Stim AID to be used in GP services to help people manage anxiety disorders

4.8 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 there is an ongoing study exploring the use of Alpha-Stim AID in primary care. It considered that the full results of this study would be valuable to consider in a future assessment.

Cost modelling overview

The EAC's updated model is acceptable but uncertainties remain

4.9 The committee considered that the position of Alpha-Stim AID treatment in the care pathway and how well different treatments work (that is, Alpha-Stim AID alone or with iCBT) was uncertain. So, it was difficult to draw firm conclusions 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.

Further information about resource use would be valuable

4.10 In the EAC's base-case analysis, 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 were needed to understand the potential resource impact of using Alpha-Stim AID in the NHS.

Further research

Further good quality research is needed to address uncertainties about the clinical efficacy of Alpha-Stim AID

4.11 Alpha-Stim AID shows potential 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, for example using electroencephalography, would be helpful. 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 iCBT. 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.

Collecting real-world data is encouraged

4.12 The committee considered that collecting real-world data on the use of Alpha-Stim AID would be useful to help understand issues such as patient treatment preferences, the uptake of the device, and the response rates and treatment completion rates in different clinical scenarios.

How are you taking part in this consultation?

Alpha-Stim AID for anxiety disorders