ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1170-6154

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tourette Syndrome

Condition category

Condition code

Neurological

Other neurological disorders

Human Genetics and Inherited Disorders

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]

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]

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]

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]

The Premonitory Urge for Tics Scale (PUTS; Woods, Piacentini, Himle, & Chang, 2005)

Timepoint [2]

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]

The Parent/Self Tic Questionnaire (PTQ; Chang, Himle, Tucker, Woods, & Piacentini, 2009)

Timepoint [3]

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]

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]

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?

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

University

Name [1]

Macquarie University

Address [1]

Macquarie University
Balaclava Road
North Ryde NSW 2109

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

UNSW Research Ethics & Compliance Support
Level 3, Rupert Myers Building (South)
The University of New South Wales
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2015

Approval date [1]

15/12/2015

Ethics approval number [1]

HC15646

Ethics committee name [2]

Macquarie University HREC

Ethics committee address [2]

Macquarie University
North Ryde NSW 2109

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/02/2016

Approval date [2]

11/04/2016

Ethics approval number [2]

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

Prof Valsamma Eapen

Address

Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170

Country

Australia

Phone

+ 61 2 9616 4205

Fax

v.eapen@unsw.edu.au

Contact person for public queries

Name

Valsamma Eapen

Address

Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170

Country

Australia

Phone

+ 61 2 9616 4205

Fax

v.eapen@unsw.edu.au

Contact person for scientific queries

Name

Valsamma Eapen

Address

Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170

Country

Australia

Phone

+ 61 2 9616 4205

Fax

v.eapen@unsw.edu.au

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.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
3992	Plain language summary	No		The tDCS intervention for children with Tourettes ... [More Details]
4540	Study results article	Yes		Journal publication	368638-(Uploaded-24-07-2021-19-08-06)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The role of transcranial direct current stimulation (tDCS) in tourette syndrome: A review and preliminary findings.	2017	https://dx.doi.org/10.3390/brainsci7120161

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically