Status:
COMPLETED
Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
Neurotherapeutics Ltd
University of Nottingham
Conditions:
Tourette Syndrome
Chronic Tic Disorder
Eligibility:
All Genders
12-90 years
Phase:
NA
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 ti...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05269953
Start Date
March 18 2022
End Date
March 5 2023
Last Update
March 13 2023
Active Locations (1)
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1
Sir Colin Campbell Building
Nottingham, Nottinghamshire, United Kingdom, NG7 2TU