Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder

NCT05269953 | Completed

• 1 other identifier: 21NS018
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Chronic Tic Disorder

Keywords

Tourette Syndrome; Median nerve stimulation; Chronic Tic Disorder

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome measure will be the scores from our core measures of tic severity (using scores from YGTSS-R). The YGTSS-R total tic severity score range from 0-50, where higher scores indicate a worse outcome. These will be used to assess any change in tic severity symptoms between groups and over the initial 4 week stimulation period.

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

Secondary Outcomes (6)

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

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

• Change in Tic impairment (as measured through subscales of YGTSS-R)

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

• Change in Quality of life (as measured by Gilles de la Tourette Syndrome - Quality of Life scale (GTS-QoL))

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

• Change in Anxiety symptoms (as measured by Becks anxiety inventory (BAI))

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

• Change in OCD symptoms as measured by (Children's) Yale-Brown Obsessive-Compulsive Scale ((C)Y-BOCS)

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

Study Arms (3)

Active stimulation

EXPERIMENTAL

Device: Active stimulation

Sham stimulation

SHAM COMPARATOR

Device: Sham stimulation

Waitlist (no stimulation)

NO INTERVENTION

Treatment as usual

Interventions

Active stimulation DEVICE

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.

Active stimulation

Sham stimulation DEVICE

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.

Sham stimulation

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• Neurotherapeutics Ltd: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Sir Colin Campbell Building

Nottingham, Nottinghamshire, NG7 2TU, United Kingdom

Location

Related Publications (23)

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MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The member of the research team performing allocation will not be involved in the collection or processing of measurement outcomes (questionnaire/ video data). This same researcher will also be responsible for assigning participants to interventions by programming the MNS devices to deliver sham/active stimulation. This member of the research team will be responsible for creating and maintaining a document which links each participants unique ID with the condition they have been assigned to. All other members of the research team, participants and legal guardians will be blind to sham/active group allocation. Participants in the waitlist group and their carers will not be blind to the group they have been allocated to. Participants allocated to the waitlist group will not be blind to the stimulation type they will receive (i.e., all participants initially allocated to the waitlist group will go on to receive active rhythmic MNS at the conclusion of their participation).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: March 8, 2022
• Study Start: March 18, 2022
• Primary Completion: September 26, 2022
• Study Completion: March 5, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)