NCT05269953: NeSTS

Median Nerve Stimulation for Tourette Syndrome and Chronic Tic Disorder

Completed NA Last updated 13 March 2023

What this trial tests

NA trial testing Active stimulation in Tourette Syndrome in 132 participants. Completed in 5 March 2023.

Timeline

18 March 2022

Primary endpoint
26 September 2022

5 March 2023

Quick facts

Lead sponsor	Nottingham University Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	132
Start date	18 March 2022
Primary completion	26 September 2022
Estimated completion	5 March 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Active stimulation
• Sham stimulation

Conditions studied

• Tourette Syndrome — all drugs for Tourette Syndrome →
• Chronic Tic Disorder — all drugs for Chronic Tic Disorder →

Sponsor

Nottingham University Hospitals NHS Trust

Who can join

Adults 12 to 90, any sex, with Tourette Syndrome or Chronic Tic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.