Results of UK-wide double-blind sham-controlled clinical trial of the Neupulse device for suppressing tics in Tourette syndrome
The trial was run by the University of Nottingham, conducted between 18th March 2022 and 5th of March 2023, sponsored by Nottingham University Hospitals NHS Trust. The aim was to evaluate the effectiveness of the Neupulse device in reducing the severity and frequency of tics in individuals with Tourette Syndrome. A total of 121 participants took part in the study and went on to receive either active or sham stimulation for 10 minutes a day for 4 weeks.
The results of the study revealed that people who received active stimulation experienced a significant reduction in the severity and frequency of their tics. On average, they saw a reduction in tic frequency of more than 25% while they received stimulation.
After using the device for 4 weeks, people who received active stimulation experienced a reduction in their tic severity of more than 35%. In total, 59% of the people who received active stimulation experienced a reduction in tic severity of at least 25% compared to baseline.
These positive results will help start the development of a commercial medical device, that will run for the next 18 months. Neupulse hope to obtain regulatory approval for a commercial device by 2025 and have a device available by 2026.