Alpha-Stim

NIHR HealthTech Research Centre Mental Health (MindTech) partnered with Electromedical Products International to support the development of their Alpha-Stim cranial electrotherapy stimulation (CES) device.

Unmet needs

Anxiety disorders affect around 1 in 10 people, and while some are effectively treated with psychotherapy or medication, waiting lists for psychotherapy can be long, and treatments are only effective in about 50% of people.
Cranial electro-stimulation (CES) is a non-invasive treatment that uses low-intensity electrical currents to modulate brain activity. When Electromedical Products International approached us, some evidence for the application of CES in anxiety already existed, but there had been no prior studies exploring clinical improvement or cost effectiveness of the treatment.

Project concept

MindTech developed the protocol for a study to assess the efficacy of Alpha-Stim for Generalised Anxiety Disorder within National Heath Service (NHS) IAPT services (Increasing Access to Psychological Therapies), and separately in a population of university students. After this initial study in anxiety had been completed, MindTech subsequently supported the company with a study exploring the application of Alpha-Stim in depression.

MindTech Role

  • MindTech worked with the company to assess the existing evidence for their product and helped them identify any gaps in the evidence that would be required by National Institute for Health and Care Excellence (NICE) and healthcare providers.
  • MindTech assisted with the design of an appropriate study, recruiting two NHS sites and supported Research Delivery Network portfolio adoption for the participation of further sites.
  • MindTech advised the company throughout the study on data collection, analysis and health economic assessment and also supported them with applications for further funding.
  • MindTech then supported the company with efforts to obtain CE marking and a National Institute for Health and Care Excellence (NICE) technology appraisal. The team advised on efficacy, effectiveness and economic evaluation criteria for NICE, European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), including Patient and Public Involvement (PPI) and health economics.

Funded by

The first study was funded by Electromedical Products International.
Subsequent studies were funded by the NIHR Applied Research Collaboration East Midlands and supported by the NIHR Nottingham Biomedical Research Centre and MindTech.

Impact

As a result of this trial, the Alpha-Stim device has now been commissioned by Nottinghamshire Healthcare NHS Foundation Trust for treatment of Generalised Anxiety Disorder and is being used across Nottinghamshire IAPT services. Since September 2016, more than 250 patients have been treated with Alpha-Stim.
The follow-on study conducted for treatment of major depressive disorder (MDD) in clinical services against a sham device demonstrated no significant benefit of Alpha-Stim in MDD without comorbid anxiety.

Project Recognition

This work was the basis for a NICE Medtech Innovation Briefing on Alpha-Stim AID for anxiety, published in September 2019 (MIB193).
A subsequent Medical Technologies Guidance appraisal (MTG56) recommended further clinical and cost effectiveness evidence was needed prior to routine adoption across the country.

What’s next?

MindTech are supporting the company to plan research to further develop their recognition by NICE.

Project partners

  • Electromedical Products International, Inc UK
  • NIHR Nottingham Biomedical Research Centre
  • NIHR Nottingham Applied Research Collaboration
  • NIHR HealthTech Research Centre Mental Health (MindTech)

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