Tourette SyndromeTIC-TDCSNCT03401996
tDCS in Tourette (TIC-TDCS)
A study testing 1 mA tDCS over bilateral SMA in people with Tourette Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- 1 mA tDCS over bilateral SMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2018to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
- 16 years of age or older.
- A "moderately ill" or worse score on the Clinical Global Impression Severity scale (CGI-S).
- A total motor tic or vocal tic severity score greater or equal to 15/25 on the Yale Global Tic Severity Scale (YGTSS) or a combined score greater than 22/50.
- Participants should be either un-medicated or on stable medication treatment for tics for the previous 3 months. If receiving botulinum toxin treatment, their enrolment should be at least 16 weeks after the last treatment session.
- Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months.
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- Have a metal object/implant in their brain, skull, scalp, or neck.
- Have an implantable device (e.g., cardiac pacemaker).
- Have a diagnosis of epilepsy or cardiac disease.
- Have a history of traumatic brain injury, learning disability or dyslexia.
- Have a severe impediment in vision or hearing.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Clinical Neurosciences, University of Calgary
Calgary, Alberta, T2N 4N1
Yamile Jasaui, MSc, 001-403-220-4992, yjasauic@ucalgary.ca
About this study
Official title: tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome
Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. sham tDCS sessions during active tic suppression, and to explore the differences in brain functional activity before and after 5 sessions of active or sham cathodal tDCS in adolescents and adults with TS. Secondary objectives include the assessment of the severity of comorbidities after 5 inhibitory tDCS sessions.
- Conditions
- Tourette Syndrome
- Being tested
- 1 mA tDCS over bilateral SMA
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mA tDCS over bilateral SMADevice
A 1mA direct current will be delivered through two 5cm x 5cm saline-soaked surface sponge electrodes by a battery-driven, constant-current stimulator (Neuroconn DC stimulator). First, the SMA will be identified based on the guidelines of the international 10-20 electrode system. The tDCS will then be applied using the following procedure:
- The head of participants will be measured to find the 'vertex' (top) of the head. This point will be used as a landmark to locate the SMA. This region corresponds to the FCZ (e.g., Legon et al., 2013).
- The return electrode will be placed over the mastoids. Once the electrodes are in position, cathodal tDCS will be applied at 1mA for 15 minutes, 2 times a day with a resting period of 20 minutes in between treatment periods, for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | Not described Receives: Device: 1 mA tDCS over bilateral SMA |
| Sham tDCS | Sham comparator | Not described Receives: Device: 1 mA tDCS over bilateral SMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.
Measured: Immediately after last tDCS session
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.
Measured: 1 week after end of intervention
Secondary outcomes (5)
Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)
Tic suppression will be measured using the Modified Rush Video-Based Tic Rating Scale through a 5 min video recording (2.5 min head and shoulders and 2.5 min whole body view). The scoring method consists of combining scores rating tic distribution (number of body areas involved, from 0 to 4), tic frequency (number of motor and phonic tics expressed from 0 to 4), and tic severity (for motor tics and for phonic tics, from 0 to 4). The total score range is 0 to 20, with higher values indicating worse outcome. Tic suppression will be expressed as suppression potency (IP), defined as follows: IP = RF-RI/RF, where RF is the Rush score during 'free' ticcing and RI the Rush score during tic suppression. Thus, the higher the IP value, the more efficient the suppression potency.
Measured: Immediately after and 1 week after last tDCS session
Adverse effects
Semistructured questionnaire on adverse effects
Measured: Immediately after and 1 week after last tDCS session
Tourette Syndrome Clinical Global Impression (TS-CGI)
The TS-CGI is a clinician-rated seven point ordinal scale that ranks current symptom severity from "normal" to "extremely severe", rating the overall adverse impact of tics, but does not assess separately the individual dimensions of tics. It shares the same composition with Clinical Global Impression of Severity scales, which are commonly used measures of symptom severity in studies of patients with psychiatric disorders.
Measured: Immediately after and 1 week after last tDCS session
Individualized-Premonitory Urge for Tics Scale (iPUTS)
The I-PUTS is a clinician-administered measure that assessed the presence, frequency, intensity, and body region location of urges for individual tics endorsed over the past week using a symptom checklist that paralleled the YGTSS. The clinician inquires about the frequency of endorsed urges on a 4-point scale (1 = "Urge occurs 0-25% of the time you do the tic" to 4 = "Urge occurs 75%-100% of the time you do the tic"). The clinician also inquires about the urge intensity on a 4-point scale (1 = "minimal intensity/urge can be ignored for a considerable amount of time" to 4 = "strong intensity/urge needs relief almost immediately"). When tics and/or urges are not endorsed, items receive a rating of 0. Finally, the clinician inquires about the body region associated with each urge. Items are summed to create a total number of distinct urges (I-PUTS Urge Number), total urge frequency (I-PUTS Frequency), and total urge intensity (I-PUTS Intensity).
Measured: Immediately after and 1 week after last tDCS session
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
The Y-BOCS is a 10-item, clinician-administered scale, that has become the most widely used rating scale for obsessive-compulsive disorder. The Y-BOCS provides five rating dimensions for obsessions and compulsions: time spent or occupied; interference with functioning or relationships; degree of distress; resistance; and control (i.e., success in resistance). The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity ranges between 0 and 40, with higher scores indicating worse outcome.
Measured: Immediately after and 1 week after last tDCS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 May 2018
- Primary completion1 Feb 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Martino, MD, PhD, Principal investigator, Department of Clinical Neurosciences, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401996
- Sponsor's protocol ID
- REB17-1615
- Acronym
- TIC-TDCS
- Status last verified
- Mar 2020
- First submitted
- 2 Jan 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome
- ClinicalTrials.gov ID
- NCT03401996
- Acronym / sponsor ID
- TIC-TDCS / REB17-1615
- Conditions
- Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. sham tDCS sessions during active tic suppression, and to explore the differences in brain functional activity before and after 5 sessions of active or sham cathodal tDCS in adolescents and adults with TS. Secondary objectives include the assessment of the severity of comorbidities after 5 inhibitory tDCS sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: 1 mA tDCS over bilateral SMA |
| Sham tDCS | Sham comparator | Device: 1 mA tDCS over bilateral SMA |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
- 16 years of age or older.
- A "moderately ill" or worse score on the Clinical Global Impression Severity scale (CGI-S).
- A total motor tic or vocal tic severity score greater or equal to 15/25 on the Yale Global Tic Severity Scale (YGTSS) or a combined score greater than 22/50.
- Participants should be either un-medicated or on stable medication treatment for tics for the previous 3 months. If receiving botulinum toxin treatment, their enrolment should be at least 16 weeks after the last treatment session.
Key exclusion criteria (6 listed)
- Have a metal object/implant in their brain, skull, scalp, or neck.
- Have an implantable device (e.g., cardiac pacemaker).
- Have a diagnosis of epilepsy or cardiac disease.
- Have a history of traumatic brain injury, learning disability or dyslexia.
- Have a severe impediment in vision or hearing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 mA tDCS over bilateral SMAA 1mA direct current will be delivered through two 5cm x 5cm saline-soaked surface sponge electrodes by a battery-driven, constant-current stimulator (Neuroconn DC stimulator). First, the SMA will be identified based on the guidelines of the international 10-20 electrode system. The tDCS will then be applied using the following procedure: 1. The head of participants will be measured to find the 'vertex' (top) of the head. This point will be used as a landmark to locate the SMA. This region corresponds to the FCZ (e.g., Legon et al., 2013). 2. The return electrode will be placed over the mastoids. Once the electrodes are in position, cathodal tDCS will be applied at 1mA for 15 minutes, 2 times a day with a resting period of 20 minutes in between treatment periods, for 5 consecutive days. | Device | Real tDCS, Sham tDCS |
Primary outcome
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
Time frame: Immediately after last tDCS session
The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
Time frame: 1 week after end of intervention
The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.
5 secondary outcomes
Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)
Time frame: Immediately after and 1 week after last tDCS session
Adverse effects
Time frame: Immediately after and 1 week after last tDCS session
Tourette Syndrome Clinical Global Impression (TS-CGI)
Time frame: Immediately after and 1 week after last tDCS session
Individualized-Premonitory Urge for Tics Scale (iPUTS)
Time frame: Immediately after and 1 week after last tDCS session
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Immediately after and 1 week after last tDCS session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Martino, MD, PhD principal investigator
Department of Clinical Neurosciences, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 mA tDCS over bilateral SMA in people with Tourette Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamile Jasaui, MSc (001-403-220-4992, yjasauic@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS) (time frame: Immediately after last tDCS session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.