Principal researcher: Dr Lisa Bunn, Plymouth University (UK)
Scientific Summary:
This project directly responds to the needs expressed by people with ataxia for non-invasive treatments to improve daily life. It aims to evaluate the effectiveness of the Exopulse “Mollii” Suit, a CE-marked, neuro-modulatory wearable device, designed to enhance motor function, balance, coordination, and quality of life. Although manufacturers claim benefits after four weeks of alternate-day use compared to comparable sham-suit use for those with hypertonia, current evidence is largely anecdotal for those with ataxia and based on low-quality studies from patient populations with mixed underlying pathologies. With a high cost of £4,000 and no NHS funding, robust, independent evaluation is urgently needed to avoid both potential health inequalities and personal financial loss if the suit is not beneficial for people with ataxia.
Therefore, the researchers propose a double-blinded randomised crossover trial with 20 people with ataxia exploring: (i) process data relating to overall trial procedures (recruitment rate, dropout and loss to follow-up), (ii) performance of the candidate future outcome measure set, (iii) technical issues and any other factors influencing participant adherence, and (iv) participants’ overall experience of the Mollii, sham-Mollii use, and trial procedures.
Lay Summary:
This research project explores the use of the Exopulse Mollii Suit, a wearable device that uses gentle electrical stimulation. This suit targets balance, coordination of movement and aims to reduce fatigue. Although the suit has been reported to help some people and is considered safe, there is little high-quality scientific evidence to support its use, especially for people with ataxia. The suit is expensive (around £4,000) and not currently funded by the NHS, meaning people must pay for it themselves, which could lead to unfair access if it proves to be beneficial, or people wasting money if it is not beneficial.
The study will recruit 20 people with ataxia and use a high-quality research design where participants will be randomly assigned to either wear the working suit or a sham (non-working) version of the suit. Both the participants and the researchers will not know whether the participants are wearing the working or sham version of the suit. The researchers aim to see whether wearing the suit for four weeks can improve everyday function in people with ataxia.
The planned effectiveness outcomes will measure changes in functional independence, and the study will also explore other measures like balance, coordination, and quality of life. The research will use both clinical assessments and advanced motion analysis technology and will also collect feedback from participants and monitor safety carefully.
A feasibility study asks whether something can be done, should we proceed with it, and if so, how. Ultimately, if feasible for 20 initial participants a future larger trial offering knowledge of effectiveness will be pursued to help guide decisions about whether or not the suit should be made more widely available and supported by public healthcare funding.
This project is due to begin on April 1st 2026.
