None listed
Conditions
Brief summary
Tourette Syndrome (TS) is a neurodevelopmental disorder with childhood onset, characterised by the presence of both motor and vocal tics (American Psychiatric Association, 2013). Once thought to be a rare disorder, the prevalence of TS is now understood to be approximately 1% in the general population (Robertson, Eapen & Cavanna, 2009). A growing body of evidence suggests that noninvasive brain stimulation techniques, including transcranial Magnetic Stimulation (TMS) and transcranial Direct Current Stimulation (tDCS), may have a promising role in the diagnosis, monitoring and treatment of a variety of neurological and psychiatric conditions, including TS. For example, TMS has been found to be safe and effective in the treatment of TS among children and adolescents (Le, Liu, Sun, Hu & Xiao, 2013; Wu, Shahana, Huddleston, Lewis & Gilbert, 2012). With the exception of a report on two adult cases (Mrakic-Sposta et al., 2008), no study to date, however, has investigated tDCS as a therapeutic intervention for TS, despite previous research demonstrating its safety and tolerability for children and adolescents with other neurological and psychiatric disorders (for a review, see Krishnan, Santos, Peterson & Ehinger, 2015). This clinical pilot study will examine the feasibility and safety of tDCS for treatment of TS in individuals aged over 12 years.
Interventions
Transcranial Direct Current Stimulation (tDCS) will be administered via sponge electrodes (stimulating electrode 25cm2) soaked in saline and held in place by a neoprene cap, with the cathode positioned over the preSMA (4cm in front of the vertex/Cz) and the return electrode positioned over the right deltoid. The current intensity will be given at between 1.0mA to 2.0mA (milliamps) for a duration of up to 30 minutes per session, dependent on participant-reported tolerability. Participants will re
Transcranial Direct Current Stimulation (tDCS) will be administered via sponge electrodes (stimulating electrode 25cm2) soaked in saline and held in place by a neoprene cap, with the cathode positioned over the preSMA (4cm in front of the vertex/Cz) and the return electrode positioned over the right deltoid. The current intensity will be given at between 1.0mA to 2.0mA (milliamps) for a duration of up to 30 minutes per session, dependent on participant-reported tolerability. Participants will receive a course of tDCS three times per week for six weeks (a total of 18 tDCS sessions). To allow for contingencies (e.g., non-attendance due to unforeseen circumstances), participants will be required to complete a minimum of two and maximum of three sessions in any one week, and complete the total 18 sessions, meaning that treatment duration could be for up to nine weeks. Participants will complete the first two treatment sessions face-to-face in order to have the procedure explained and to ascertain the tolerability and any potential side-effects of the treatment. Participants will be able to complete subsequent treatment sessions at their home using a portable unit. Settings on the unit will be programmed by a study investigator, and these are unable to be changed by the participant. Sessions conducted at participants' homes will be supervised remotely by a study investigator.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant aged over 12 years. 2. Participant meets criteria for a primary diagnosis of DSM-5 Tourette’s Disorder: presence of multiple motor and one or more vocal tics which have persisted for more than one year with onset before 18 years of age (American Psychiatric Association, 2013). 3. Participants taking psychotropic medications to manage tics will be included as long as the dose had been stable for at least six weeks prior to participation, with no planned changes during the course of the study.
Exclusion criteria
1. Unacceptable risk factors for unsafe administration or side effects of tDCS (implanted cranial devices; previous head or brain injury; skin lesions on scalp at proposed electrode sites; epilepsy or history of seizures; drug abuse). 2. Participants who are not fluent in English will be excluded from the trial for safety reasons. It is usually not possible to have an interpreter readily available every weekday for up to four weeks and it is not safe to administer tDCS to a participant who cannot immediately inform us of any side effects (e.g., development of skin irritation during stimulation). 3. Participant has a primary psychiatric or medical diagnosis apart from Tourette's Disorder. While participants with comorbidities commonly associated with a primary diagnosis of Tourette's Disorder (such as Obsessive-Compulsive Disorder and Attention Deficit Hyperactivity Disorder) will not be excluded, those with any major psychiatric conditions such as psychosis, bipolar disorder etc will be excluded. 4. Pregnancy.
Outcome results
None listed