CompletedNot Applicable

Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder

United Kingdom132 participantsStarted 2022-03-18

Plain-language summary

Tourette syndrome (TS) and chronic tic disorder (CTD) are neurodevelopmental disorders that impact approximately 1% of 5-18 year olds worldwide. Both TS and CTD are characterised by the presence of tics, which are repetitive, purposeless, movements or vocalisations of short duration which can occur many times throughout a day. Tics can have a significant negative impact on daily functioning and quality of life, hence, many seek out approaches to manage and reduce their tics and the urges people with TS or CTD often feel preceding them. The two main evidence-based approaches to treating tics are behavioural therapies and medication; both of which can be effective, but accessibility and waitlists are often an issue for behavioural therapies and side effects are common with medication use. Consequently, there is an urgent need for the development of alternative, safe and accessible treatments. This study aims to examine the effects of rhythmic pulses of electrical stimulation delivered to the wrist in treating tics in people with TS and CTD. In recent work, the investigators have shown that this type of electrical stimulation known as median nerve stimulation (MNS), can substantially reduce tics and related urges during stimulation. The investigators now want to extend this work to examine the effects of the stimulation on a higher number of people, compared to placebo and treatment as usual. The investigators will do this through assessment of symptom change using questionnaires, interviews and videos collection during four weeks of stimulation and two time points afterwards. The investigators have developed a new MNS device for this trial which is portable and easy to use. The primary hypothesis is that active rhythmic MNS will lead to a reduction in tic severity compared to a placebo condition. The secondary hypothesis is that MNS will also have a positive beneficial effect on urges, impairment, well-being and co-occurring Obsessive-Compulsive Disorder (OCD) symptoms compared to both sham stimulation and no stimulation.

Who can participate

Age range12 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 12 years or older. Must also be able to give informed consent (along with parents/guardians). * Confirmed or suspected diagnosis of Tourette Syndrome or Chronic Tic Disorder with a moderate amount of tics (to be assessed during an initial screening interview). * Stable treatment regime/no treatment for the past 2 months (i.e. if taking medication same drug \& dosage). * Internet access \& access to electronic device to complete online questionnaires and video calls. * Participants must be able to travel to Nottingham for one visit and have reliable access to the internet. * Participant is willing and able to give informed consent for participation in the clinical investigation. * Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements * Resident in the UK Exclusion Criteria: * Current diagnosis of epilepsy. * Participant or participants guardian (if under 16) unable to read/write in English. * Participants will be excluded from the trial if they find the stimulation too uncomfortable during a practice session at the in person baseline visit. * Individuals with implanted electronic devices (e.g. pacemakers, insulin pump, implantable cardioverter defibrillator, neurostimulators). * Individuals sharing the household with an individual with implanted electronic devices (e.g. pacemakers, insulin pump, implantable cardioverter defibrillator, neurostimulators). * Individuals with current/ recent diagnosis o…

What they're measuring

Change in Yale Global Tic Severity Scale - revised (YGTSS-R) total tic severity score

Timeframe: Baseline, week 1, 2, 3 and 4, and at follow-up points 3 and 6 months after starting stimulation

Trial details

NCT IDNCT05269953

SponsorNottingham University Hospitals NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-26