Neupulse: A new wrist device that help to control symptoms of Tourette syndrome reducing the severity and frequency of tics

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Tourette syndrome referred to as Tourette disorder in the recently updated Diagnostic and Statistical Manual of Mental Disorders (DSM–5), is a common neurodevelopmental disorder affecting up to 1% of the population.

It is characterized by multiple motor and vocal tics and starts in childhood. Children with Gilles de la Tourette syndrome (GTS) sometimes experience physical pain, social isolation, emotional disturbance, and are at risk for underachievement.

It is difficult to distinguish whether these experiences are the result of the tics themselves or the fact that most children with Tourette syndrome also have other comorbid neuropsychiatric conditions such as attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), anxiety disorder, or oppositional defiant disorder (ODD).

The pathophysiology and genetic basis for GTS are not well understood despite many in-depth studies. Pharmacological treatment is not usually indicated, as children respond well to comprehensive behavioral intervention for tics (CBIT).

Teacher and caregiver education can have a positive impact on the social experience of a child struggling with Tourette syndrome. The prognosis is variable, as tics typically remit by adulthood, but the other neuropsychiatric conditions may persist.[1][2][3][4]

The new research and prototipe ….

Tourette syndrome (TS) and chronic tic disorder (CTD) are neurological disorders of childhood onset characterised by the occurrence of tics; repetitive, purposeless, movements or vocalisations of short duration which can occur many times throughout a day.

Currently, effective treatment for tic disorders is an area of considerable unmet clinical need. We aimed to evaluate the efficacy of a home-administered neuromodulation treatment for tics involving the delivery of rhythmic pulse trains of median nerve stimulation (MNS) delivered via a wearable ‘watch-like’ device worn at the wrist. We conducted a UK-wide parallel double-blind sham-controlled trial for the reduction of tics in individuals with tic disorder.

The device was programmed to deliver rhythmic (10Hz) trains of low-intensity (1-19 mA) electrical stimulation to the median nerve for a pre-determined duration each day, and was intended to be used by each participant in their home once each day, 5 days each week, for a period of 4 weeks. Between 18th March 2022 and 26th September 2022 135 participants (45 per group) were initially allocated, using stratified randomisation, to one of the following groups; active stimulation; sham stimulation; or a to waitlist (i.e., treatment as usual) control group.

Recruited participants were individuals with confirmed or suspected TS/CTD aged 12 years of age or upward with moderate to severe tics. Researchers involved in the collection or processing of measurement outcomes and assessing the outcomes, as well as participants in the active and sham groups and their legal guardians were all blind to the group allocation.

The primary outcome measure used to assess the ‘offline’ or treatment effect of stimulation was the Yale Global Tic Severity Scale – Total Tic Severity Score (YGTSS-TTSS) assessed at the conclusion of 4-weeks of stimulation. The primary outcome measure used to assess the ‘online’ effects of stimulation was tic frequency, measured as the number of tics per minute (TPM) observed, based upon blind analysis of daily video recordings obtained while stimulation was delivered.

source: https://www.neupulse.co.uk/

The results demonstrated that after 4-weeks stimulation, tic severity (YGTSS-TTSS) had reduced by 7.1 points (35% reduction) for the active stimulation group compared to 2.13/2.11points for the sham stimulation and waitlist control groups.

The reduction in YGTSS-TTSS for the active stimulation group was substantially larger, clinically meaningful (effect size = 0.5), and statistically significant (p = 0.02) compared to both the sham stimulation and waitlist control groups, which did not differ from one another (effect-size = -0.03).

Furthermore, blind analyses of video recordings demonstrated that tic frequency (tics per minute) reduced substantially (−15.6 TPM) during active stimulation compared to sham stimulation (−7.7 TPM).

This difference represents a statistically significant (p < 0.03) and clinically meaningful reduction in tic frequency (> 25% reduction: effect-size = 0.3).

These findings indicate that home-administered rhythmic MNS delivered through a wearable wrist-worn device has potential as an effective community-based treatment for tic disorders


reference link : https://www.ncbi.nlm.nih.gov/books/NBK499958/

Original Research: Closed access.
A double-blind, sham-controlled, trial of home-administered rhythmic 10Hz median nerve stimulation for the reduction of tics, and suppression of the urge-to-tic, in individuals with Tourette syndrome and chronic tic disorder” by Barbara Morera Maiquez et al. MedRxiv

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