Tourette SyndromeNeSTSNCT05269953
Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder
A study testing Active stimulation in people with Tourette Syndrome and Chronic Tic Disorder, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder
- What is being tested?
- Active stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2022to 5 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 or symptoms of SARS-CoV-2 will not be invited to visit the university until it is safe for them to do so (2 weeks following positive test).
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- Individuals with a diagnosis of non-verbal autism or similar condition which would affect ability to give informed consent to take part in the study will not be recruited.
- Pregnant women will not be recruited for this study.
- Participants who have participated in previous research studies involving median nerve stimulation
- Participants aged over 90 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir Colin Campbell Building
Nottingham, Nottinghamshire, NG7 2TU
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Trial of Rhythmic 10Hz Median Nerve Stimulation for the Suppression of the Urge-to-tic and Reduction of Tics in Individuals With Tourette Syndrome and Chronic Tic Disorder
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.
Read the detailed description
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:
- Participants who have expressed an interest in the study will be given a detailed participant information sheet. Participants will be given the opportunity to ask questions about the study. If participants wish to proceed and to have an initial telephone screening to assess eligibility participants will then be asked to complete an initial consent form which will asked for their consent to take part in the screening and for the research team to keep a record of their answers during that process.
- Consenting participants will then be contacted by a member of the research team at an agreed time via telephone/video call. This call should last no longer than an hour. This will be used to give participants further insights into the trial and to establish trial eligibility. Trial eligibility will be assessed according to the investigators' predefined inclusion/ exclusion criteria. The YGTSS, semi structured interview will also be conducted by a trained member of the research team to establish If the potential participant has enough tics to be eligible for the trial.
- After completing the telephone screening, eligible participants will be sent a further electronic consent form to take part in the rest of the trial. After obtaining consent, participants will be allocated into a trial arm and a date will be set for them to visit Nottingham. In the case of the wait list group participants will not visit Nottingham until participants have entered into the open label active phase of the trial.
- During the baseline visit to the University of Nottingham, participants will receive the stimulation device and will be trained in its correct placement and use. In order to ensure participant's comfort with the stimulation, a practice session will be performed. If the participant experiences significant discomfort, participants will be withdrawn from the trial. On the same day, demographic information along with primary and secondary measures will be collected using various questionnaires and structured interviews. Participants in the waitlist group will also complete these measurements online and through video call.
- Participants in the active and placebo groups will return home with the device and be instructed to commence stimulation sessions on the following Monday. Participants will be asked to use the device once each day, 5 days each week, for a period of 4 weeks. During the stimulation period participants will be asked to complete a few short questions each day which should take 1-2 minutes. Participants will also be contacted by a member of the research team at weeks 1, 2, 3 and 4 of stimulation and 3 and 6 months after completing stimulation. During these meetings through video call lasting approximately 1 hour various semi-structured interviews and questionnaires will be administered to assess changes in symptoms. A subset of participants will also be asked to record videos of themselves 5 minutes before the stimulation, during the stimulation and 5minutes after the stimulation and to upload these to a secure online platform. These will be used by the research team to objectively count changes in tics.
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.
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Being tested
- Active stimulation, Sham stimulation
- Keywords
- Tourette Syndrome, Median nerve stimulation, Chronic Tic Disorder
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stimulationDevice
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.
Sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Not described Receives: Device: Active stimulation |
| Sham stimulation | Sham comparator | Not described Receives: Device: Sham stimulation |
| Waitlist (no stimulation) | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4 after starting stimulation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 4 after starting stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start18 Mar 2022
- Primary completion26 Sep 2022
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated into three groups (ratio: 1:1:1): active stimulation, sham stimulation and waitlist (no stimulation). Those in the waitlist group would receive treatment as normal, prior to an open label phase of receiving active stimulation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Neurotherapeutics Ltd, University of Nottingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269953
- Sponsor's protocol ID
- 21NS018
- Acronym
- NeSTS
- Status last verified
- Jul 2024
- First submitted
- 7 Jan 2022
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
PubMed 24001701Robertson MM, Eapen V, Cavanna AE. The international prevalence, epidemiology, and clinical phenomenology of Tourette syndrome: a cross-cultural perspective. J Psychosom Res. 2009 Dec;67(6):475-83. doi: 10.1016/j.jpsychores.2009.07.010.
PubMed 19913651Cohen SC, Leckman JF, Bloch MH. Clinical assessment of Tourette syndrome and tic disorders. Neurosci Biobehav Rev. 2013 Jul;37(6):997-1007. doi: 10.1016/j.neubiorev.2012.11.013. Epub 2012 Dec 1.
PubMed 23206664Cavanna AE, Black KJ, Hallett M, Voon V. Neurobiology of the Premonitory Urge in Tourette's Syndrome: Pathophysiology and Treatment Implications. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):95-104. doi: 10.1176/appi.neuropsych.16070141. Epub 2017 Jan 25.
PubMed 28121259Leckman JF, Walker DE, Cohen DJ. Premonitory urges in Tourette's syndrome. Am J Psychiatry. 1993 Jan;150(1):98-102. doi: 10.1176/ajp.150.1.98.
PubMed 8417589Freeman RD, Fast DK, Burd L, Kerbeshian J, Robertson MM, Sandor P. An international perspective on Tourette syndrome: selected findings from 3,500 individuals in 22 countries. Dev Med Child Neurol. 2000 Jul;42(7):436-47. doi: 10.1017/s0012162200000839.
PubMed 10972415Conelea CA, Woods DW, Zinner SH, Budman C, Murphy T, Scahill LD, Compton SN, Walkup J. Exploring the impact of chronic tic disorders on youth: results from the Tourette Syndrome Impact Survey. Child Psychiatry Hum Dev. 2011 Apr;42(2):219-42. doi: 10.1007/s10578-010-0211-4.
PubMed 21046225Conelea CA, Woods DW, Zinner SH, Budman CL, Murphy TK, Scahill LD, Compton SN, Walkup JT. The impact of Tourette Syndrome in adults: results from the Tourette Syndrome impact survey. Community Ment Health J. 2013 Feb;49(1):110-20. doi: 10.1007/s10597-011-9465-y. Epub 2011 Nov 4.
PubMed 22052430Robertson MM. Mood disorders and Gilles de la Tourette's syndrome: An update on prevalence, etiology, comorbidity, clinical associations, and implications. J Psychosom Res. 2006 Sep;61(3):349-58. doi: 10.1016/j.jpsychores.2006.07.019.
PubMed 16938513Fernandez de la Cruz L, Rydell M, Runeson B, Brander G, Ruck C, D'Onofrio BM, Larsson H, Lichtenstein P, Mataix-Cols D. Suicide in Tourette's and Chronic Tic Disorders. Biol Psychiatry. 2017 Jul 15;82(2):111-118. doi: 10.1016/j.biopsych.2016.08.023. Epub 2016 Aug 26.
PubMed 27773353Whittington C, Pennant M, Kendall T, Glazebrook C, Trayner P, Groom M, Hedderly T, Heyman I, Jackson G, Jackson S, Murphy T, Rickards H, Robertson M, Stern J, Hollis C. Practitioner Review: Treatments for Tourette syndrome in children and young people - a systematic review. J Child Psychol Psychiatry. 2016 Sep;57(9):988-1004. doi: 10.1111/jcpp.12556. Epub 2016 May 2.
PubMed 27132945Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.
PubMed 21445724Hollis C, Pennant M, Cuenca J, Glazebrook C, Kendall T, Whittington C, Stockton S, Larsson L, Bunton P, Dobson S, Groom M, Hedderly T, Heyman I, Jackson GM, Jackson S, Murphy T, Rickards H, Robertson M, Stern J. Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis. Health Technol Assess. 2016 Jan;20(4):1-450, vii-viii. doi: 10.3310/hta20040.
PubMed 26786936Azrin NH, Nunn RG. Habit-reversal: a method of eliminating nervous habits and tics. Behav Res Ther. 1973 Nov;11(4):619-28. doi: 10.1016/0005-7967(73)90119-8. No abstract available.
PubMed 4777653Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.
PubMed 20483969
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Trial of Rhythmic 10Hz Median Nerve Stimulation for the Suppression of the Urge-to-tic and Reduction of Tics in Individuals With Tourette Syndrome and Chronic Tic Disorder
- ClinicalTrials.gov ID
- NCT05269953
- Acronym / sponsor ID
- NeSTS / 21NS018
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Keywords
- Tourette Syndrome, Median nerve stimulation, Chronic Tic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Neurotherapeutics Ltd, University of Nottingham
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Participants who have expressed an interest in the study will be given a detailed participant information sheet. Participants will be given the opportunity to ask questions about the study. If participants wish to proceed and to have an initial telephone screening to assess eligibility participants will then be asked to complete an initial consent form which will asked for their consent to take part in the screening and for the research team to keep a record of their answers during that process.
- Consenting participants will then be contacted by a member of the research team at an agreed time via telephone/video call. This call should last no longer than an hour. This will be used to give participants further insights into the trial and to establish trial eligibility. Trial eligibility will be assessed according to the investigators' predefined inclusion/ exclusion criteria. The YGTSS, semi structured interview will also be conducted by a trained member of the research team to establish If the potential participant has enough tics to be eligible for the trial.
- After completing the telephone screening, eligible participants will be sent a further electronic consent form to take part in the rest of the trial. After obtaining consent, participants will be allocated into a trial arm and a date will be set for them to visit Nottingham. In the case of the wait list group participants will not visit Nottingham until participants have entered into the open label active phase of the trial.
- During the baseline visit to the University of Nottingham, participants will receive the stimulation device and will be trained in its correct placement and use. In order to ensure participant's comfort with the stimulation, a practice session will be performed. If the participant experiences significant discomfort, participants will be withdrawn from the trial. On the same day, demographic information along with primary and secondary measures will be collected using various questionnaires and structured interviews. Participants in the waitlist group will also complete these measurements online and through video call.
- Participants in the active and placebo groups will return home with the device and be instructed to commence stimulation sessions on the following Monday. Participants will be asked to use the device once each day, 5 days each week, for a period of 4 weeks. During the stimulation period participants will be asked to complete a few short questions each day which should take 1-2 minutes. Participants will also be contacted by a member of the research team at weeks 1, 2, 3 and 4 of stimulation and 3 and 6 months after completing stimulation. During these meetings through video call lasting approximately 1 hour various semi-structured interviews and questionnaires will be administered to assess changes in symptoms. A subset of participants will also be asked to record videos of themselves 5 minutes before the stimulation, during the stimulation and 5minutes after the stimulation and to upload these to a secure online platform. These will be used by the research team to objectively count changes in tics.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated into three groups (ratio: 1:1:1): active stimulation, sham stimulation and waitlist (no stimulation). Those in the waitlist group would receive treatment as normal, prior to an open label phase of receiving active stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: Active stimulation |
| Sham stimulation | Sham comparator | Device: Sham stimulation |
| Waitlist (no stimulation) | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active stimulationParticipants 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. | Device | Active stimulation |
| Sham stimulationParticipants 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. | Device | Sham stimulation |
Primary outcome
Change in Yale Global Tic Severity Scale - Revised (YGTSS-R) Total Tic Severity Score
Time frame: Baseline and week 4 after starting stimulation
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.
3 secondary outcomes
Change in Tic Frequency as Quantified by Analysis of Video Data
Time frame: Pre-stimulation period and During stimulation period
Change in Premonitory Urge (as Measured by Premonitory Urge for Tics Scale-Revised (PUTS-R))
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)
Time frame: Baseline and week 4 after starting stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24001701Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
- Background: PubMed 19913651Robertson MM, Eapen V, Cavanna AE. The international prevalence, epidemiology, and clinical phenomenology of Tourette syndrome: a cross-cultural perspective. J Psychosom Res. 2009 Dec;67(6):475-83. doi: 10.1016/j.jpsychores.2009.07.010.
- Background: PubMed 23206664Cohen SC, Leckman JF, Bloch MH. Clinical assessment of Tourette syndrome and tic disorders. Neurosci Biobehav Rev. 2013 Jul;37(6):997-1007. doi: 10.1016/j.neubiorev.2012.11.013. Epub 2012 Dec 1.
- Background: PubMed 28121259Cavanna AE, Black KJ, Hallett M, Voon V. Neurobiology of the Premonitory Urge in Tourette's Syndrome: Pathophysiology and Treatment Implications. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):95-104. doi: 10.1176/appi.neuropsych.16070141. Epub 2017 Jan 25.
- Background: PubMed 8417589Leckman JF, Walker DE, Cohen DJ. Premonitory urges in Tourette's syndrome. Am J Psychiatry. 1993 Jan;150(1):98-102. doi: 10.1176/ajp.150.1.98.
- Background: PubMed 10972415Freeman RD, Fast DK, Burd L, Kerbeshian J, Robertson MM, Sandor P. An international perspective on Tourette syndrome: selected findings from 3,500 individuals in 22 countries. Dev Med Child Neurol. 2000 Jul;42(7):436-47. doi: 10.1017/s0012162200000839.
- Background: PubMed 21046225Conelea CA, Woods DW, Zinner SH, Budman C, Murphy T, Scahill LD, Compton SN, Walkup J. Exploring the impact of chronic tic disorders on youth: results from the Tourette Syndrome Impact Survey. Child Psychiatry Hum Dev. 2011 Apr;42(2):219-42. doi: 10.1007/s10578-010-0211-4.
- Background: PubMed 22052430Conelea CA, Woods DW, Zinner SH, Budman CL, Murphy TK, Scahill LD, Compton SN, Walkup JT. The impact of Tourette Syndrome in adults: results from the Tourette Syndrome impact survey. Community Ment Health J. 2013 Feb;49(1):110-20. doi: 10.1007/s10597-011-9465-y. Epub 2011 Nov 4.
- Background: PubMed 16938513Robertson MM. Mood disorders and Gilles de la Tourette's syndrome: An update on prevalence, etiology, comorbidity, clinical associations, and implications. J Psychosom Res. 2006 Sep;61(3):349-58. doi: 10.1016/j.jpsychores.2006.07.019.
- Background: PubMed 27773353Fernandez de la Cruz L, Rydell M, Runeson B, Brander G, Ruck C, D'Onofrio BM, Larsson H, Lichtenstein P, Mataix-Cols D. Suicide in Tourette's and Chronic Tic Disorders. Biol Psychiatry. 2017 Jul 15;82(2):111-118. doi: 10.1016/j.biopsych.2016.08.023. Epub 2016 Aug 26.
- Background: PubMed 27132945Whittington C, Pennant M, Kendall T, Glazebrook C, Trayner P, Groom M, Hedderly T, Heyman I, Jackson G, Jackson S, Murphy T, Rickards H, Robertson M, Stern J, Hollis C. Practitioner Review: Treatments for Tourette syndrome in children and young people - a systematic review. J Child Psychol Psychiatry. 2016 Sep;57(9):988-1004. doi: 10.1111/jcpp.12556. Epub 2016 May 2.
- Background: PubMed 21445724Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active stimulation in people with Tourette Syndrome and Chronic Tic Disorder, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Global Tic Severity Scale - Revised (YGTSS-R) Total Tic Severity Score (time frame: Baseline and week 4 after starting stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05269953, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.