A 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
| Autor: | Morera Maiquez, Barbara, Dyke, Katherine, Jackson, Georgina M., Jackson, Stephen R. |
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| Jazyk: | angličtina |
| Předmět: | |
| ISSN: | 1748-6645 1748-6653 |
| Popis: | Tourette syndrome (TS) and chronic tic disorder (CTD) are neurodevelopmental disorders that are characterised by the occurrence of tics; repetitive, purposeless, movements or vocalisations of short duration which can occur many times throughout a day. One of the defining characteristics of tics, and one that distinguishes them from other kinds of abnormal movement, is that they can often be suppressed for a period of time. However, tic suppression is invariably associated with increasing levels of discomfort which is most often experienced as a strong urge-to-tic (PU). Importantly, PU are uncomfortable sensory phenomena, often described as feelings of discomfort or pressure which can be temporally reduced after tic execution. Individuals who experience PU often report that: these experiences are more bothersome than their tics; that expressing their tics give them relief from, and temporarily abolishes, their PU; and that they would not exhibit tics if they did not experience PU. For this reason, PU might be considered as the driving force behind the occurrence of tics. Currently effective treatment for TS is an area of considerable unmet clinical need. Furthermore, when individuals with TS are asked to comment on research priorities for TS, they frequently state that developing a low-cost, safe and effective, non-drug treatment for controlling tics and the urge-to-tic, that would be suitable for administration outside of the clinic, should be of the highest priority. We propose to conduct a parallel, double-blind, placebo-controlled trial of a wearable, wrist-worn, therapeutic device for the suppression of PU and the reduction of tics in individuals with TS. The device is 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 will be used by each participant from home once each day, 5 days each week, for a period of 4 weeks. A total of 135 participants (45 per group) will be randomly allocated to an; active stimulation; sham stimulation; or waitlist (i.e., treatment as usual) group using Randola (http://rando.la/). Recruited participants will be individuals with confirmed or suspected Tourette syndrome/Chronic tic disorder aged 12 years upward with moderate to severe tics. Participants with epilepsy will be excluded. 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 will be blinded to the group allocation.Primary measurements of the effects of stimulation will focus on standard clinical measures of tic severity and the urge-to-tic. Additional analyses will evaluate changes in quality-of-life and symptoms linked to frequency of co-occurring clinical conditions. Follow-up assessments will take place at 3 months and 6 months after the trial commenced. The primary hypothesis is that active rhythmic MNS will lead to a reduction in tic severity compared to sham stimulation. |
| Databáze: | OpenAIRE |
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