Evidence generation plan for digital therapy for chronic tic disorders and Tourette syndrome: Neupulse

6 Implementation considerations

The following considerations around implementing the evidence generation process have been identified through working with system partners:

Technology

  • Neupulse is still under development and is anticipated to be ready for market in 2026. Modifications to the product in newer versions may impact clinical and cost effectiveness.

  • The product will initially be sold direct-to-customer.

  • The appropriateness of behavioural therapies or median nerve stimulation should be assessed on an individual basis.

  • The app associated with the technology enables the user to modify frequency and strength of median nerve stimulation. Only evidence using the lowest setting was identified. The impact of changing these settings is unknown.

System considerations

  • There is high variation in services available to the population. The contributing services or centres should be chosen to maximise the generalisability of evidence generated, for example including groups of people with different socioeconomic status, or to improve data collection for any relevant subgroups. Developers should provide clear descriptions of the services and settings in which the study is done, and the characteristics of the people in the trial.

  • There is an unmet need for diagnosing and treating tic disorders and Tourette syndrome, and access to treatment also varies across the NHS. This will bias which centres or services are selected for data collection. This could also bias which centres adopt the technology and increase health inequalities.

  • The technology is intended for use on an ad-hoc basis to control tic symptoms. This should be considered in the study design.

Evidence generation

  • Evidence generation should be overseen by a steering group including researchers, commissioners, healthcare professionals, and people with lived experience. 

  • The evidence generation process is most likely to succeed with dedicated research staff to reduce the burden on NHS staff, and by using suitable real-world data to collect information when possible.

  • Careful planning of the approach to information governance is vital. The developer should ensure that appropriate structures and policies are in place to ensure that the data is handled in a confidential and secure manner, and to appropriate ethical and quality standards.

  • Once the evidence generation period has concluded, ideally further data about the clinical impact of the digitally enabled therapy for chronic tic disorders and Tourette syndrome could be collected to support planning and decision making.

Accessibility

  • The technology may not be suitable for everyone, for example people without access to, or who cannot use, a smartphone or computer. People with cognitive impairment, problems with manual dexterity or learning disabilities may need additional help for carers or advocates.

  • The technology could be more beneficial if it is set up to ensure that language and cultural considerations of its users are met, and the digital literacy of people using the technology is considered.

  • People from ethnic minority backgrounds are underrepresented in terms of accessing the appropriate services for tic disorders and Tourette's syndrome. This could impact study recruitment and access to the technology.

Safety

  • Neupulse offers several different settings for median nerve stimulation that can be adjusted by the user through the app. Evidence is needed to understand the clinical impact of the user switching between the settings.

ISBN: 978-1-4731-6994-4

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