ClinicalTrials.gg
Not yet recruitingNCT07838428LETITTICUpdated Sep 24, 2026

Let It TiC in Childhood Provisional Eye Tic

An interventional study of Reducing Attentional Interventions Therapy Treatment and Continue with the previous treatment plan in Tic Disorder and Provisional Tic Disorder, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tic Disorder
  • Provisional Tic Disorder

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Keywords

  • tic disorder
  • provisional tic disorder
  • behavioral intervention
03

In context

Tic Disorders

102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.

This study's planned enrollment of 134 is above the median of 50 across 83 interventional studies indexed under Tic Disorders.

Browse Tic Disorders studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: Between 6 and 14 years old
  2. the diagnosis is PTD characterized by abnormal blinking as the main manifestation
  3. The legal guardian agrees and signs the form, and complies with the research protocol

Exclusion criteria

Exclusion Criteria:

  1. Received any other behavioral intervention treatment or took related therapeutic drugs within the past 3 months.
  2. The current active allergic diseases
  3. There are any eye disorders that may cause confusion in the interpretation of the research results
  4. Having worn contact lenses within the past 3 months
  5. The researchers determined that the participants were not suitable to participate in this study due to other reasons
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Behavioral intervention

    The behavioral intervention group received the attention reduction intervention therapy.

    Behavioral: Reducing Attentional Interventions Therapy Treatment

  • Sham comparator
    Control group

    The control group did not receive the intervention therapy aimed at reducing attention, and subsequently was transferred to the attention reduction intervention therapy.

    Other: Continue with the previous treatment plan

Interventions

  • BehavioralReducing Attentional Interventions Therapy Treatment

    Reducing Attentional Interventions Therapy Treatment

  • OtherContinue with the previous treatment plan

    Continue with the previous treatment plan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 6 months

Secondary outcomes

  1. YGTSS impairment subscale

    Total score range: 0 - 50 points,A training evaluator and the guardian jointly completed

    Time frame: through study completion, an average of 6 months

  2. 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.

    Time frame: through study completion, an average of 6 months

  3. Self-Rating Depression Scale(SDS)

    Number of items: 20,Data source: Filled out by the primary guardian

    Time frame: through study completion, an average of 6 months

  4. 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

    Time frame: through study completion, an average of 6 months

07

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510080
    Guangzhou, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.

Of 39 non-industry interventional studies with no phase under Tic Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's planned 38 months is above that.

Counting every sponsor, half of 39 studies reached it within 28 months; a quarter within 16 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Sep 24, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2030
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07838428
Responsible party
Liang Dan (Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Sep 24, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 24, 2026

Study contacts

Dan Liang professor
Contact
wuhaoeye@163.com
0086-020-87330402

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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