Evidence generation plan

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 not be available to the NHS, but will be sold direct-to-customer.

Training for health professionals and users is not provided by the company.

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.

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.

The company does not provide training for staff to support use of the technology.

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 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 company 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.

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.

The company intends to sell devices direct to customers in 2026. This could lead to socio-economic biases in future cohorts. It will be important to collect this data in the baseline information (see section 3.3).

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.