Tourette's SyndromePhase 1/2NCT02112253
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
A Phase 1/2 study testing Deep brain stimulator ventral electrode up to 2 mA, Deep brain stimulator ventral electrode up to 3 mA and Deep brain stimulator dorsal electrode up to 2 mA in people with Tourette's Syndrome, run by The University of Western Australia at 1 site in Australia.
Trial summary
The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Tourette's Syndrome
- What is being tested?
- Deep brain stimulator ventral electrode up to 2 mA, Deep brain stimulator ventral electrode up to 3 mA and Deep brain stimulator dorsal electrode up to 2 mA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2013to 14 May 2021
- Phase
- Phase 1/2
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14 to 60 years
- Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication
Who cannot join
- Surgical contraindications to deep brain stimulation surgery
- Major Depressive Episode within the previous 6 months
- Schizophrenia or other psychotic disorder
- Personality disorder impairing ability to reliably comply with study protocol
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
About this study
Official title: Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.
- Conditions
- Tourette's Syndrome
- Being tested
- Deep brain stimulator ventral electrode up to 2 mA, Deep brain stimulator ventral electrode up to 3 mA, Deep brain stimulator dorsal electrode up to 2 mA, Deep brain stimulator dorsal electrode up to 3 mA, Deep brain stimulator empirical programming
- Keywords
- Tourette's syndrome, Deep brain stimulation, Stereotactic surgery, Globus pallidus interna, Tics
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulator ventral electrode up to 2 mADevice
Deep brain stimulator ventral electrode up to 3 mADevice
Deep brain stimulator dorsal electrode up to 2 mADevice
Deep brain stimulator dorsal electrode up to 3 mADevice
Deep brain stimulator empirical programmingDevice
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulator ventral electrode up to 2 mA | Experimental | The ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first. Receives: Device: Deep brain stimulator ventral electrode up to 2 mA |
| Deep brain stimulator ventral electrode up to 3 mA | Experimental | The ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first. Receives: Device: Deep brain stimulator ventral electrode up to 3 mA |
| Deep brain stimulator dorsal electrode up to 2 mA | Experimental | The dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first. Receives: Device: Deep brain stimulator dorsal electrode up to 2 mA |
| Deep brain stimulator dorsal electrode up to 3 mA | Experimental | The dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first. Receives: Device: Deep brain stimulator dorsal electrode up to 3 mA |
| Deep brain stimulator empirical programming | Active comparator | Any of the four electrode contacts on each of the two deep brain stimulation leads can be activated in any combination with any amplitude, frequency or pulse width settings to achieve optimized clinical control of motor tics whilst minimizing side effects. Both programmer and patient may be unblinded. The assessors are blinded to stimulation settings. Receives: Device: Deep brain stimulator empirical programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
Performed before surgery.
Measured: At baseline
Yale Global Tic Severity Scale (YGTSS)
At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Secondary outcomes (35)
Modified Rush Video Rating Scale and tic counts
Performed before surgery.
Measured: At baseline
Modified Rush Video Rating Scale and tic counts
At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Modified Rush Video Rating Scale and tic counts
At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Modified Rush Video Rating Scale and tic counts
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Modified Rush Video Rating Scale and tic counts
At the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Modified Rush Video Rating Scale and tic counts
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Tourette's syndrome symptom list
Performed before surgery.
Measured: At baseline
Tourette's syndrome symptom list
At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Tourette's syndrome symptom list
At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Tourette's syndrome symptom list
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Tourette's syndrome symptom list
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 12 months
Tourette's syndrome symptom list
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Short Form 36
Quality of life outcome measure. Performed before surgery.
Measured: At baseline
Short Form 36
Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Short Form 36
Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Short Form 36
Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Short Form 36
Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Short Form 36
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Montreal Cognitive Assessment (MoCA)
Performed before surgery.
Measured: At baseline
Montreal Cognitive Assessment (MoCA)
At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Montreal Cognitive Assessment (MoCA)
At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Montreal Cognitive Assessment (MoCA)
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Montreal Cognitive Assessment (MoCA)
At the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Montreal Cognitive Assessment (MoCA)
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Performed before surgery.
Measured: At baseline
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
At the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
At the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
At the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
At the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
At the end of the 6 month non-randomized empirical stimulation period.
Measured: 18 months
Adverse effects list
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the first of four three-month randomized blinded stimulation periods.
Measured: 3 months
Adverse effects list
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the second of four three-month randomized blinded stimulation periods.
Measured: 6 months
Adverse effects list
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the third of four three-month randomized blinded stimulation periods.
Measured: 9 months
Adverse effects list
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the last of four three-month randomized blinded stimulation periods.
Measured: 12 months
Adverse effects list
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the 6 month non-randomized empirical stimulation period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMar 2013
- Primary completion14 May 2021
- Study completion14 May 2021 (estimated)
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science
- Responsible party
- Principal investigator, Professor Christopher Lind, The University of Western Australia
- Investigators
- Christopher Lind, FRACS, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112253
- Sponsor's protocol ID
- 2012-120
- Status last verified
- May 2021
- First submitted
- 22 Mar 2014
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
- ClinicalTrials.gov ID
- NCT02112253
- Acronym / sponsor ID
- 2012-120
- Conditions
- Tourette's Syndrome
- Keywords
- Tourette's syndrome, Deep brain stimulation, Stereotactic surgery, Globus pallidus interna, Tics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science
- Study start
- Mar 2013
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- 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.
The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulator ventral electrode up to 2 mA | Experimental | Device: Deep brain stimulator ventral electrode up to 2 mAThe ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first. |
| Deep brain stimulator ventral electrode up to 3 mA | Experimental | Device: Deep brain stimulator ventral electrode up to 3 mAThe ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first. |
| Deep brain stimulator dorsal electrode up to 2 mA | Experimental | Device: Deep brain stimulator dorsal electrode up to 2 mAThe dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first. |
| Deep brain stimulator dorsal electrode up to 3 mA | Experimental | Device: Deep brain stimulator dorsal electrode up to 3 mAThe dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first. |
| Deep brain stimulator empirical programming | Active comparator | Device: Deep brain stimulator empirical programmingAny of the four electrode contacts on each of the two deep brain stimulation leads can be activated in any combination with any amplitude, frequency or pulse width settings to achieve optimized clinical control of motor tics whilst minimizing side effects. Both programmer and patient may be unblinded. The assessors are blinded to stimulation settings. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 14 to 60 years
- Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication
Key exclusion criteria (5 listed)
- Surgical contraindications to deep brain stimulation surgery
- Major Depressive Episode within the previous 6 months
- Schizophrenia or other psychotic disorder
- Personality disorder impairing ability to reliably comply with study protocol
- Significant cognitive impairment
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 |
|---|---|---|
| Deep brain stimulator ventral electrode up to 2 mA | Device | Deep brain stimulator ventral electrode up to 2 mA |
| Deep brain stimulator ventral electrode up to 3 mA | Device | Deep brain stimulator ventral electrode up to 3 mA |
| Deep brain stimulator dorsal electrode up to 2 mA | Device | Deep brain stimulator dorsal electrode up to 2 mA |
| Deep brain stimulator dorsal electrode up to 3 mA | Device | Deep brain stimulator dorsal electrode up to 3 mA |
| Deep brain stimulator empirical programming | Device | Deep brain stimulator empirical programming |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: At baseline
Performed before surgery.
Yale Global Tic Severity Scale (YGTSS)
Time frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
Yale Global Tic Severity Scale (YGTSS)
Time frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
Yale Global Tic Severity Scale (YGTSS)
Time frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
Yale Global Tic Severity Scale (YGTSS)
Time frame: 12 months
At the end of the last of four three-month randomized blinded stimulation periods.
Yale Global Tic Severity Scale (YGTSS)
Time frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
35 secondary outcomes
Modified Rush Video Rating Scale and tic counts
Time frame: At baseline
Modified Rush Video Rating Scale and tic counts
Time frame: 3 months
Modified Rush Video Rating Scale and tic counts
Time frame: 6 months
Modified Rush Video Rating Scale and tic counts
Time frame: 9 months
Modified Rush Video Rating Scale and tic counts
Time frame: 12 months
Modified Rush Video Rating Scale and tic counts
Time frame: 18 months
Tourette's syndrome symptom list
Time frame: At baseline
Tourette's syndrome symptom list
Time frame: 3 months
Tourette's syndrome symptom list
Time frame: 6 months
Tourette's syndrome symptom list
Time frame: 9 months
Tourette's syndrome symptom list
Time frame: 12 months
Tourette's syndrome symptom list
Time frame: 18 months
Short Form 36
Time frame: At baseline
Short Form 36
Time frame: 3 months
Short Form 36
Time frame: 6 months
Short Form 36
Time frame: 9 months
Short Form 36
Time frame: 12 months
Short Form 36
Time frame: 18 months
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline
Montreal Cognitive Assessment (MoCA)
Time frame: 3 months
Montreal Cognitive Assessment (MoCA)
Time frame: 6 months
Montreal Cognitive Assessment (MoCA)
Time frame: 9 months
Montreal Cognitive Assessment (MoCA)
Time frame: 12 months
Montreal Cognitive Assessment (MoCA)
Time frame: 18 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: At baseline
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: 3 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: 6 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: 9 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: 12 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time frame: 18 months
Adverse effects list
Time frame: 3 months
Adverse effects list
Time frame: 6 months
Adverse effects list
Time frame: 9 months
Adverse effects list
Time frame: 12 months
Adverse effects list
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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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.
Christopher Lind, FRACS principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deep brain stimulator ventral electrode up to 2 mA, Deep brain stimulator ventral electrode up to 3 mA and Deep brain stimulator dorsal electrode up to 2 mA in people with Tourette's Syndrome, run by The University of Western Australia at 1 site in Australia.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 May 2021. 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 Australia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) (time frame: At baseline). The study lists 6 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 18 May 2021.