Median Nerve Stimulation Pilot (NCT04731714) | Clinical Trial Compass
CompletedNot Applicable
Median Nerve Stimulation Pilot
United States34 participantsStarted 2021-07-15
Plain-language summary
Results from the University of Nottingham suggested that rhythmic median nerve stimulation (MNS) improves tic symptoms in Tourette syndrome (TS). The investigators will (1) provide a first replication of their study, (2) test the hypothesized electrophysiological mechanism and rule out a placebo effect as cause for the symptomatic benefit, and (3) gather information on the duration of effect after the end of stimulation and on individual characteristics that predict improvement with simulation. Completion of these Aims will give a clear go/no-go signal for a future clinical trial of chronic MNS delivered by a yet-to-be-developed wristwatch-style device.
NOTE: This study is not intended to evaluate a specific device for future use. Rather it is a study to determine the action of pulsed electrical stimulation on tic symptoms and to gain early evidence of effectiveness. This is a non-significant risk device study.
Who can participate
Age range
15 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 15-64 inclusive at initial screening visit
* Informed consent by adult subject; assent by child and informed consent by guardian
* Current Tourette's Disorder or Persistent (Chronic) Tic Disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5
* At least 1 tic per minute (average) during the first 5-min. baseline video session on the first visit (as scored during the session by the investigator)
Exclusion Criteria:
* Unable to complete study procedures for any reason
* Has an implanted device that could be affected by electrical current
* Pregnancy known to participant or (for children) to the parent
* Known or suspected primary genetic syndrome (e.g. Down syndrome, Fragile X)
* Intellectual disability (known, or likely from history and examination)
* Head trauma with loss of consciousness for more than 5 minutes
* Significant neurologic disease, not counting TS (exceptions include febrile seizures or uncomplicated migraine)
* Severe or unstable systemic illness
* Factors (such as exaggerated signs) that in the judgment of the principal investigator make the video recording or YGTSS an inaccurate assessment of tic severity
* Judged by investigator to be unlikely to complete study procedures or to return for later visits
* Change in somatic or psychotherapeutic treatment in the 2 weeks preceding the first stimulation visit
* Planned change in somatic or psychotherapeutic treatment between t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Tic Frequency From When MNS is Turned Off
Timeframe: During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)
2
Change in Tic Severity From When MNS is Turned Off
Timeframe: During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)
3
Change in Tic Frequency During Rhythmic MNS (vs. Arrhythmic MNS)
Timeframe: During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9
4
Change in Tic Severity During Rhythmic MNS (vs. Arrhythmic MNS)
Timeframe: During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9