Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder

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Brief Title

Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder

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

Brief 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.
    

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:

        1. 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.

        2. 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.

        3. 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.

        4. 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.

        5. 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 Type

Interventional


Primary Outcome

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

Secondary Outcome

 Change in Premonitory urge for Tics Scale-Revised (PUTS-R)

Condition

Tourette Syndrome

Intervention

Active stimulation

Study Arms / Comparison Groups

 Active stimulation
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

132

Start Date

March 18, 2022

Completion Date

March 1, 2023

Primary Completion Date

September 23, 2022

Eligibility Criteria

        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 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).

          -  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
      

Gender

All

Ages

12 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT05269953

Organization ID

21NS018


Responsible Party

Sponsor

Study Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

 Neurotherapeutics Ltd

Study Sponsor

, , 


Verification Date

September 2022