Trial Outcomes & Findings for Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder (NCT NCT05269953)

Recruited participants were individuals who contacted us directly expressing an interest in taking part in this research following media coverage about this and following the advertisement of the clinical trial on social media by the UK charity Tourette's Action.

A total of 210 potential participants consented to participate in the screening interview. However, 25 participants did not proceed to attend the interview, and 19 participants were subsequently excluded after their suitability to participate in the trial was assessed. Additionally, 23 participants were excluded before the baseline visit, and an additional 10 participants were excluded during the baseline visit. Thus, 133 participants were enrolled in the trial and randomised.

Race and Ethnicity were not collected from any participant.

The primary outcome measure were the scores from our core measures of tic severity (using scores from YGTSS-R). The YGTSS-R total tic severity score ranges from 0-50, where higher scores indicate a worse outcome. These were used to assess any change in tic severity symptoms between groups and over the initial 4 week stimulation period. YGTSS-R is recognised as the gold standard measure for evaluating tic severity in Tourette syndrome.

This outcome measure explored the changes in tic frequency occurring during stimulation and 5-min period immediately prior to stimulation, through the use of video data in a subgroup of participants. Video data analyses are based on 82 video sessions from 16 participants receiving active stimulation and 91 video sessions from 17 participants receiving sham stimulation. For each session, the change in tic frequency was calculated by subtracting tics per minute (TPM) in the period during stimulation with TPM measured during the 5-min period immediately prior to stimulation.

This outcome measure will evaluate the treatment effects of MNS on the frequency of the urge to tic by looking at change in scores from the PUTS-R. The PUTS-R is a 24 item self-report instrument which is specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders. The PUTS-R scores range from 0-32, where higher scores indicate worse outcome.

This outcome measure will evaluate the treatment effects of MNS on OCD symptoms by looking at change in scores from the (C)Y-BOCS. The age-appropriate version of this semi-structured interview was used to assess symptoms of OCD. The first part of the scale involves assessing what potential obsessions/compulsions an individual has experienced over the course of the past week, followed by assessment of the time spent, interference and distress caused by, ability to resist and control over obsessions compulsions. The (C)Y-BOCS scores range from 0-40, where higher scores indicate worse outcome.

This outcome measure will evaluate the treatment effects of MNS on well-being by looking at change in scores from the GTS-QoL. The GTS-QoL scores range from 0-100, where higher scores indicate worse outcome. This questionnaire includes a visual analog scale ranging 0-100 assessing how satisfied the person feels in their life, higher scores indicating a better outcome.