Tic DisorderLETITTICNCT07838428
Let It TiC in Childhood Provisional Eye Tic
A study testing Reducing Attentional Interventions Therapy Treatment and Continue with the previous treatment plan in people with Tic Disorder and Provisional Tic Disorder, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Tic Disorder, Provisional Tic Disorder
- What is being tested?
- Reducing Attentional Interventions Therapy Treatment and Continue with the previous treatment plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: Between 6 and 14 years old
- the diagnosis is PTD characterized by abnormal blinking as the main manifestation
- The legal guardian agrees and signs the informed consent form, and complies with the research protocol
Who cannot join
- Received any other behavioral intervention treatment or took related therapeutic drugs within the past 3 months.
- The current active allergic diseases
- There are any eye disorders that may cause confusion in the interpretation of the research results
- Having worn contact lenses within the past 3 months
- The researchers determined that the participants were not suitable to participate in this study due to other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510080
Guangzhou
dan,liang, 0086-020-66607666, wuhaoeye@163.com
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Attention Reduction Intervention Therapy for Children With Transient Tic Disorder Primarily Characterized by Abnormal Blinking
Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior
Read the detailed description
Children diagnosed clinically with PTD primarily characterized by abnormal blinking were recruited from multiple clinical centers and randomly assigned to two groups. The behavioral intervention group received "attention-reduction intervention therapy," while the control group continued with their previous clinical treatment regimen. After the initial observation period, participants in both groups crossed over to receive the same attention-reduction intervention therapy for an additional treatment cycle. The study evaluated changes in Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS) scores at the end of each intervention cycle compared to baseline. This study is designed as a prospective, multicenter, randomized, controlled clinical trial to validate these findings.
- Conditions
- Tic Disorder, Provisional Tic Disorder
- Being tested
- Reducing Attentional Interventions Therapy Treatment, Continue with the previous treatment plan
- Keywords
- tic disorder, provisional tic disorder, behavioral intervention
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Attentional Interventions Therapy TreatmentBehavioural
Reducing Attentional Interventions Therapy Treatment
Continue with the previous treatment planOther
Continue with the previous treatment plan
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | The behavioral intervention group received the attention reduction intervention therapy. Receives: Behavioral: Reducing Attentional Interventions Therapy Treatment |
| Control group | Sham comparator | The control group did not receive the intervention therapy aimed at reducing attention, and subsequently was transferred to the attention reduction intervention therapy. Receives: Other: Continue with the previous treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Yale Comprehensive Tics Severity Scale
Three evaluation researchers who had undergone unified training and were unaware of the group assignments independently conducted blinded scoring based on the standardized protocol and the medical records provided by the same guardian of the patients. The average value was then calculated.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
YGTSS impairment subscale
Total score range: 0 - 50 points，A training evaluator and the guardian jointly completed
Measured: through study completion, an average of 6 months
ocular and systemic Adverse Events (AEs)
ocular and systemic AEs will be summarized descriptively, including the number and proportion of participants with any adverse event or specific adverse-event subcategory, such as ocular versus non-ocular events, adverse events of special interest, and events leading to study discontinuation. If the severity grade changes, the event will be summarized according to the highest grade. Systemic and ocular adverse events will be summarized separately.
Measured: through study completion, an average of 6 months
Self-Rating Depression Scale(SDS)
Number of items: 20,Data source: Filled out by the primary guardian
Measured: through study completion, an average of 6 months
Gilles de la Tourette Syndrome-Quality of Life scale(GTS-QOL)
Number of items: 24, Data source: Filled out by the child and/or the primary caregiver
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic DisorderStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Dan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838428
- Sponsor's protocol ID
- LET IT TIC
- Acronym
- LETITTIC
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of Attention Reduction Intervention Therapy for Children With Transient Tic Disorder Primarily Characterized by Abnormal Blinking
- ClinicalTrials.gov ID
- NCT07838428
- Acronym / sponsor ID
- LETITTIC / LET IT TIC
- Conditions
- Tic Disorder, Provisional Tic Disorder
- Keywords
- tic disorder, provisional tic disorder, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Sep 2026 (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.
Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior
Detailed description
Children diagnosed clinically with PTD primarily characterized by abnormal blinking were recruited from multiple clinical centers and randomly assigned to two groups. The behavioral intervention group received "attention-reduction intervention therapy," while the control group continued with their previous clinical treatment regimen. After the initial observation period, participants in both groups crossed over to receive the same attention-reduction intervention therapy for an additional treatment cycle. The study evaluated changes in Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS) scores at the end of each intervention cycle compared to baseline. This study is designed as a prospective, multicenter, randomized, controlled clinical trial to validate these findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Reducing Attentional Interventions Therapy TreatmentThe behavioral intervention group received the attention reduction intervention therapy. |
| Control group | Sham comparator | Other: Continue with the previous treatment planThe control group did not receive the intervention therapy aimed at reducing attention, and subsequently was transferred to the attention reduction intervention therapy. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: Between 6 and 14 years old
- the diagnosis is PTD characterized by abnormal blinking as the main manifestation
- The legal guardian agrees and signs the informed consent form, and complies with the research protocol
Key exclusion criteria (5 listed)
- Received any other behavioral intervention treatment or took related therapeutic drugs within the past 3 months.
- The current active allergic diseases
- There are any eye disorders that may cause confusion in the interpretation of the research results
- Having worn contact lenses within the past 3 months
- The researchers determined that the participants were not suitable to participate in this study due to other reasons
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 |
|---|---|---|
| Reducing Attentional Interventions Therapy TreatmentReducing Attentional Interventions Therapy Treatment | Behavioural | Behavioral intervention |
| Continue with the previous treatment planContinue with the previous treatment plan | Other | Control group |
Primary outcome
Score of the Yale Comprehensive Tics Severity Scale
Time frame: through study completion, an average of 6 months
Three evaluation researchers who had undergone unified training and were unaware of the group assignments independently conducted blinded scoring based on the standardized protocol and the medical records provided by the same guardian of the patients. The average value was then calculated.
4 secondary outcomes
YGTSS impairment subscale
Time frame: through study completion, an average of 6 months
ocular and systemic Adverse Events (AEs)
Time frame: through study completion, an average of 6 months
Self-Rating Depression Scale(SDS)
Time frame: through study completion, an average of 6 months
Gilles de la Tourette Syndrome-Quality of Life scale(GTS-QOL)
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tic Disorder
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Attentional Interventions Therapy Treatment and Continue with the previous treatment plan in people with Tic Disorder and Provisional Tic Disorder, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang professor (0086-020-87330402, wuhaoeye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Yale Comprehensive Tics Severity Scale (time frame: through study completion, an average of 6 months). 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 24 Sep 2026.