An interventional study of Active stimulation and Sham stimulation in Tourette Syndrome and Chronic Tic Disorder, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Nottingham University Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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.
The symptoms of Tourette Syndrome (TS) (tics and premonitory urges) can be treated using behavioural therapies and/or medications, however access, availability, side effects and treatment resistance are factors which many people with TS and their family's express frustration with. Therefore, it is in the interest of patients and the wider medical community that alternative treatments are tested and scientifically validated. In recent work, the investigators have found that low intensity electrical stimulation delivered to the wrist can be effective in significantly reducing tics and tic related premonitory urges. In the study the investigators want to expand this work to examine the effects of the stimulation on a higher number of people, compared to placebo and treatment as usual and to examine the suitability of a wearable device for delivering stimulation from home.
The investigators will conduct a parallel, double-blind, placebo-controlled trial of a wearable, wrist-worn, therapeutic device for the suppression of premonitory urge and the reduction of tics in individuals with TS. In order to validate the device as a genuine and effective form of therapy, it is essential that a placebo branch of the study is completed. Participants will be made aware of the three different experimental arms ahead of enrolment and will be debriefed following completion of the trial. The investigators are committed to clearly explaining why a placebo condition is essential, while minimising the amount of information the investigators withhold from participants, hence the investigators feel it is important to be able to let participants know the condition participants were in at the end of the trial.
The device the investigators are aiming to trial will be programmed to deliver low-intensity (1-19 mA) rhythmic (10Hz) trains of electrical stimulation to the median nerve for 14 minutes, and will be used by each participant from home once each day, 5 days each week, for a period of 4 weeks. Participants assigned to the active condition will experience rhythmic (10Hz) trains of stimulation set to an individual intensity which the investigators have found to be effective in the investigators' previous work (-120% of intensity needed to generate a visible muscle twitch in the thenar muscle). Those assigned to the placebo group will receive stimulation at a subthreshold rate (50% intensity needed to generate thenar muscle twitch). The investigators' previous work suggests that this serves as a sufficient control condition. Those in the waitlist group would receive treatment as normal, prior to an open label phase of receiving active stimulation.
A total of 135 participants (45 per group) will be allocated to one of the three groups; active stimulation; sham stimulation; or waitlist (i.e., treatment as usual). In order to minimise the difference in age, gender and symptom severity between groups, the investigators will perform a stratified randomisation for age, gender and severity (using Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score) to allocate individuals to each group.
The effects of the stimulation will be assessed using several semi-structured interviews, questionnaire measures and video recordings of participant's tics. The investigators will also use questionnaire measures/ interviews to measure baseline characteristics of the participants, as these factors may influence response to the investigators proposed intervention. The majority of this trial will be remotely supervised and therefor the majority of these measures will also be taken through video call and online questionnaire measures with the exception of an initial visit to the University of Nottingham.
The primary hypothesis is that active MNS will lead to a reduction in tic severity compared to subthreshold placebo stimulation. The procedure for testing this will be as follows:
The investigators estimate that the trial will take 9 months to collect all data sets, including the 6 month follow up period. Visits to Nottingham will take place during the first 3 months of the trial.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 135 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Active stimulation
Device: Sham stimulation
Treatment as usual.
Participants assigned to the active stimulation arm will receive rhythmic MNS 2 minutes on and 1 minute off for 15 minutes. The strength of the stimulation will be set to 120% the intensity needed to produce a visible contraction within the thenar muscle.
Participants assigned to the sham stimulation arm will receive rhythmic MNS 2 minutes on and 1 minute off for 15 minutes. The strength of the stimulation will be set to 50% the intensity needed to produce a visible contraction within the thenar muscle.
Change in Yale Global Tic Severity Scale - Revised (YGTSS-R) Total Tic Severity Score
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.
Time frame: Baseline and week 4 after starting stimulation
Change in Tic Frequency as Quantified by Analysis of Video Data
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.
Time frame: Pre-stimulation period and During stimulation period
Change in Premonitory Urge (as Measured by Premonitory Urge for Tics Scale-Revised (PUTS-R))
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.
Time frame: Baseline and week 4 after starting stimulation
Change in Symptoms of Obsessive-Compulsive Disorder (OCD) (as Measured by (Children's) Yale-Brown Obsessive-Compulsive Scale (C)Y-BOCS)
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.
Time frame: Baseline and week 4 after starting stimulation
Change in Quality of Life (as Measured by Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QoL))
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.
Time frame: Baseline and week 4 after starting stimulation
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.
| Milestone | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) |
|---|---|---|---|
| Started | 44 | 44 | 45 |
| Completed 4 week assessments | 40 | 39 | 41 |
| Completed | 35 | 35 | 41 |
| Not completed | 9 | 9 | 4 |
| Withdrew: Lost to follow-up | 5 | 4 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 4 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Technical difficulties with device | 0 | 2 | 0 |
| Withdrew: Not committed to the trial | 0 | 2 | 0 |
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.
| Score on a scale | Active Stimulation | Sham Stimulation | Waitlist |
|---|---|---|---|
| Change in Yale Global Tic Severity Scale - Revised (YGTSS-R) Total Tic Severity Score | -7.13 ± 1.1 | -2.13 ± 0.32 | -2.26 ± 0.34 |
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.
| Tics per minute | Active Stimulation | Sham Stimulation | Waitlist |
|---|---|---|---|
| Change in Tic Frequency as Quantified by Analysis of Video Data | -15.6 ± 36.6 | -7.7 ± 17.3 | — |
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.
| Score on a scale | Active Stimulation | Sham Stimulation | Waitlist |
|---|---|---|---|
| Change in Premonitory Urge (as Measured by Premonitory Urge for Tics Scale-Revised (PUTS-R)) | -22.2 ± 37.0 | -16.1 ± 24.2 | -9.3 ± 25.9 |
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.
| Score on a scale | Active Stimulation | Sham Stimulation | Waitlist |
|---|---|---|---|
| Change in Symptoms of Obsessive-Compulsive Disorder (OCD) (as Measured by (Children's) Yale-Brown Obsessive-Compulsive Scale (C)Y-BOCS) | -24.9 ± 38.4 | -35.5 ± 41.2 | -18.9 ± 45.5 |
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.
| Score on a scale | Active Stimulation | Sham Stimulation | Waitlist |
|---|---|---|---|
| Change in Quality of Life (as Measured by Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QoL)) | -6.7 ± 19.3 | -8.4 ± 12.5 | -2.8 ± 10.7 |
Collected over Adverse event data were collected from each participant from the date the participant was enrolled in the study until their withdrawal or the conclusion of their 6-month follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Stimulation | 0/44 (0%) | 0/44 (0%) | 8/44 (18.2%) |
| Sham Stimulation | 0/44 (0%) | 0/44 (0%) | 4/44 (9.1%) |
| Waitlist (no Stimulation) | 0/45 (0%) | 1/45 (2.2%) | 0/45 (0%) |
| Event | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) |
|---|---|---|---|
| Tic attackNervous system disorders | 0/44 | 0/44 | 1/45 |
| Event | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) |
|---|---|---|---|
| Electrodes in contact with skinSkin and subcutaneous tissue disorders | 8/44 | 4/44 | 0/45 |
Baseline population excludes enrolled participants who were withdrawn before the week1 assessments
| Age, Continuous(years) | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) | Total |
|---|---|---|---|---|
| Mean | 23.5 ± 12.6 | 24.0 ± 13.4 | 24.4 ± 12.6 | 23.9 ± 12.8 |
| Sex: Female, Male(Participants) | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) | Total |
|---|---|---|---|---|
| Female | 15 | 16 | 15 | 46 |
| Male | 26 | 23 | 26 | 75 |
| Race and Ethnicity Not Collected(Participants) | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Tic severity(score on a scale) | Active Stimulation | Sham Stimulation | Waitlist (no Stimulation) | Total |
|---|---|---|---|---|
| Mean | 40.1 ± 7.0 | 39.5 ± 6.3 | 38.9 ± 6.9 | 39.5 ± 6.7 |
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