Status:
COMPLETED
Median Nerve Stimulation Pilot
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Tourette Syndrome
Tic Disorders
Eligibility:
All Genders
15-64 years
Phase:
NA
Brief 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...
Detailed Description
Chronic tic disorders (CTD), including Tourette syndrome (TS), are associated with a substantially reduced quality of life. Medication treatments are no more than 50-60% effective in randomized contro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04731714
Start Date
July 15 2021
End Date
April 27 2022
Last Update
October 5 2023
Active Locations (1)
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1
Washington University School of Medicine, Movement Disorders Center
St Louis, Missouri, United States, 63110