N/A
N=32
Median Nerve Stimulation Pilot
Tourette Syndrome · Tic Disorders · Tic Disorder, Chronic Motor or Vocal
Bottom Line
View on ClinicalTrials.gov: NCT04731714 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Tic Frequency From When MNS is Turned Off — 12.1; 8.9 Tic frequency (number of tics in 40 s) — p=0.0104
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rhythmic median nerve stimulation (Device); Arrhythmic median nerve stimulation (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tic Frequency From When MNS is Turned Off |
12.1; 8.9 | 0.0104 sig |
| PRIMARY Change in Tic Severity From When MNS is Turned Off |
2.5; 2.3 | 0.079 |
| PRIMARY Change in Tic Frequency During Rhythmic MNS (vs. Arrhythmic MNS) |
85.8; 63.3; 74.2; 57.7; 65.0; 85.9 | 0.9222 |
| PRIMARY Change in Tic Severity During Rhythmic MNS (vs. Arrhythmic MNS) |
3.4; 3.2; 3.4; 3.0; 3.1; 3.3 | 0.7995 |
| SECONDARY Change in Tic Severity After MNS Ends |
7.1; 12; 8; 10 | 0.3140 |
| SECONDARY CGI-I, Participant |
2.69; 2.39 | — |
| SECONDARY CGI-I, Investigator |
2.41; 2.56 | — |
| SECONDARY Rating of Therapeutic Effect Using the CGI Efficacy Index |
20; 23 | — |
| SECONDARY VAS (Visual Analog Scale) Rating of Premonitory Urge Severity |
50.1; 36.5; 43.0; 32.0; 38.4; 50.3 | 0.8844 |
| SECONDARY Rating of Discomfort Using the CGI Efficacy Index (Edited) |
57 | — |
| SECONDARY Blindedness Assessment |
30; 34 | 0.73 |
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.
Eligibility Criteria
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 the 2 stimulation visits
Data sourced from ClinicalTrials.gov (NCT04731714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.