Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000592549
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
5/06/2015
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of transcranial Direct Current Stimulation (tDCS) as a therapeutic intervention for Tourette Syndrome
Scientific title
Does transcranial Direct Current Stimulation (tDCS) result in a reduction in the severity and frequency of tics in individuals with Tourette Syndrome?
Secondary ID [1] 286805 0
Nil
Universal Trial Number (UTN)
U1111-1170-6154
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tourette Syndrome 295179 0
Condition category
Condition code
Neurological 295428 295428 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 295475 295475 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291964 0
Treatment: Devices
Comparator / control treatment
We will test the participants in a cross-over design whereby four participants will receive sham sessions for three weeks followed by six weeks of tDCS while the other four will receive six weeks of active sessions followed by three weeks of sham sessions. The control treatment is therefore sham tDCS. There is no washout period between the two treatment periods.
Control group
Placebo

Outcomes
Primary outcome [1] 295161 0
The National Hospital Interview Schedule for the assessment of Gilles de la Tourette syndrome (NHIS) which includes the Yale Global Tic Severity Rating Scale (Robertson & Eapen, 1996)
Timepoint [1] 295161 0
For all participants, the NHIS, including the YGTSS, will be administered at baseline. The YGTSS will be administered at week 3, week 6, week 9, and then three months and six months post-treatment.
Primary outcome [2] 295203 0
The Premonitory Urge for Tics Scale (PUTS; Woods, Piacentini, Himle, & Chang, 2005)
Timepoint [2] 295203 0
For all participants, the PUTS will be administered at baseline, week 3, week 6, week 9, and then three months and six months post-treatment.
Primary outcome [3] 295204 0
The Parent/Self Tic Questionnaire (PTQ; Chang, Himle, Tucker, Woods, & Piacentini, 2009)
Timepoint [3] 295204 0
For all participants, the PTQ will be administered at baseline, week 3, week 6, week 9, and then three months and six months post-treatment.
Secondary outcome [1] 314909 0
Laboratory-based assessment of inhibitory function will be assessed by a task based on the foreperiod go/no-go task introduced by Los (2013).
Timepoint [1] 314909 0
For all participants, inhibitory function will be assessed at baseline, week 3, week 6, week 9, and six months post-treatment.

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
We will test the participants in a cross-over design whereby four participants will receive sham sessions for three weeks followed by six weeks of tDCS while the other four will receive six weeks of active sessions followed by three weeks of sham sessions.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Eight participants will be recruited for this initial clinical pilot study. As this is not a definitive RCT, sample size is not based on formal power calculations based on effect sizes. The proposed sample size is comparable to that used in several trials of non-invasive brain stimulation procedures among children and adolescents (for a review, see Krishnan et al., 2015). All outcome measures will be tested for any differences between baseline ratings and subsequent ratings with paired-samples t-tests/repeated measures ANOVAs. Statistical tests will be two-tailed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2016
Actual
10/07/2016
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291349 0
Self funded/Unfunded
Name [1] 291349 0
Country [1] 291349 0
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 290028 0
University
Name [1] 290028 0
Macquarie University
Address [1] 290028 0
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country [1] 290028 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292910 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 292910 0
UNSW Research Ethics & Compliance Support
Level 3, Rupert Myers Building (South)
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 292910 0
Australia
Date submitted for ethics approval [1] 292910 0
31/08/2015
Approval date [1] 292910 0
15/12/2015
Ethics approval number [1] 292910 0
HC15646
Ethics committee name [2] 294866 0
Macquarie University HREC
Ethics committee address [2] 294866 0
Macquarie University
North Ryde NSW 2109
Ethics committee country [2] 294866 0
Australia
Date submitted for ethics approval [2] 294866 0
23/02/2016
Approval date [2] 294866 0
11/04/2016
Ethics approval number [2] 294866 0
5201600123

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57610 0
Prof Valsamma Eapen
Address 57610 0
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 57610 0
Australia
Phone 57610 0
+ 61 2 9616 4205
Fax 57610 0
Email 57610 0
[email protected]
Contact person for public queries
Name 57611 0
Prof Valsamma Eapen
Address 57611 0
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 57611 0
Australia
Phone 57611 0
+ 61 2 9616 4205
Fax 57611 0
Email 57611 0
[email protected]
Contact person for scientific queries
Name 57612 0
Prof Valsamma Eapen
Address 57612 0
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 57612 0
Australia
Phone 57612 0
+ 61 2 9616 4205
Fax 57612 0
Email 57612 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3992Plain language summaryNo The tDCS intervention for children with Tourettes ... [More Details]
4540Study results articleYes Journal publication 368638-(Uploaded-24-07-2021-19-08-06)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe role of transcranial direct current stimulation (tDCS) in tourette syndrome: A review and preliminary findings.2017https://dx.doi.org/10.3390/brainsci7120161
N.B. These documents automatically identified may not have been verified by the study sponsor.