CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled / 135 target
Drug / intervention
Active 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/NCT05269953
NCT05269953N/ACompletedHigh Momentum (2.6/mo)Completion was 45mo ago

A Randomised, Double-blind, Placebo-controlled, Trial of Rhythmic 10Hz Median Nerve Stimulation for the Suppression of the Urge-to-tic and Reduction of Tics in Individuals With Tourette Syndrome and Chronic Tic Disorder

Nottingham University Hospitals NHS Trust·interventional·Posted Mar 8, 2022·Updated Jun 30, 2026

In Brief

A clinical study evaluating Active stimulation and Sham stimulation for Tourette Syndrome and Chronic Tic Disorder. Completed, enrolled 135 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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 tics, which are repetitive, purposeless, movements or vocalisations of short duration which can occur many times throughout a day. Tics can have a significant negative impact on daily functioning and quality of life, hence, many seek out approaches to manage and reduce their tics and the urges people with TS or CTD often feel preceding them. The two main evidence-based approaches to treating tics are behavioural therapies and medication; both of which can be effective, but accessibility and waitlists are often an issue for behavioural therapies and side effects are common with medication use. Consequently, there is an urgent need for the development of alternative, safe and accessible treatments. This study aims to examine the effects of rhythmic pulses of electrical stimulation delivered to the wrist in treating tics in people with TS and CTD. In recent work, the investigators have shown that this type of electrical stimulation known as median nerve stimulation (MNS), can substantially reduce tics and related urges during stimulation. The investigators now want to extend this work to examine the effects of the stimulation on a higher number of people, compared to placebo and treatment as usual. The investigators will do this through assessment of symptom change using questionnaires, interviews and videos collection during four weeks of stimulation and two time points afterwards. The investigators have developed a new MNS device for this trial which is portable and easy to use. The primary hypothesis is that active rhythmic MNS will lead to a reduction in tic severity compared to a placebo condition. The secondary hypothesis is that MNS will also have a positive beneficial effect on urges, impairment, well-being and co-occurring Obsessive-Compulsive Disorder (OCD) symptoms compared to both sham stimulation and no stimulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 8, 2022
Enrollment StartMar 18, 2022
Primary CompletionSep 26, 2022
Study CompletionMar 5, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.3 years ago

Arms & Interventions

Active stimulationexperimental

Device: Active stimulation
Sham stimulationsham_comparator

Device: Sham stimulation
Waitlist (no stimulation)no_intervention

Treatment as usual.

Interventions

Active stimulationdevice

Participants assigned to the active stimulation arm will receive rhythmic MNS 2 minutes on and 1 minute off for 15 minutes. The strength of the stimulation will be set to 120% the intensity needed to produce a visible contraction within the thenar muscle.

Sham stimulationdevice

Participants assigned to the sham stimulation arm will receive rhythmic MNS 2 minutes on and 1 minute off for 15 minutes. The strength of the stimulation will be set to 50% the intensity needed to produce a visible contraction within the thenar muscle.