CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Rhythmic median nerve stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04731714
NCT04731714N/ACompleted
CompareCT.gov

Peripheral Induction of Inhibitory Brain Circuits to Treat Tourette's: Pilot

Washington University School of Medicine·interventional·Posted Feb 1, 2021·Updated Oct 5, 2023

In Brief

A clinical study evaluating Rhythmic median nerve stimulation and Arrhythmic median nerve stimulation for Tourette Syndrome and 2 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome, Tic Disorders, Tic Disorder, Chronic Motor or Vocal
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 1, 2021
Enrollment StartJul 15, 2021
Primary CompletionApr 27, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.4 years ago

Interventions

Rhythmic median nerve stimulationdevice

Square-wave 200 µs pulses triggered by computer at 12 Hz, at the threshold for thumb movement (expected \~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.

Arrhythmic median nerve stimulationdevice

Square-wave 200 µs pulses triggered by computer at random intervals with a mean rate of 12 Hz (as described in Morera Maiquez et al., 2020), at the threshold for thumb movement (expected \~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.