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NCT Number: NCT07838428

Let It TiC in Childhood Provisional Eye Tic

Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior

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Key information

Conditions

Tic Disorder Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders Provisional Tic Disorder Tic Disorders

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510080

Guangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Reducing Attentional Interventions Therapy Treatment

Behavioral

Reducing Attentional Interventions Therapy Treatment

Continue with the previous treatment plan

Other

Continue with the previous treatment plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. YGTSS impairment subscale

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

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

  2. ocular and systemic Adverse Events (AEs)

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

    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.

  3. Self-Rating Depression Scale(SDS)

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

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

  4. Gilles de la Tourette Syndrome-Quality of Life scale(GTS-QOL)

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

    Number of items: 24, Data source: Filled out by the child and/or the primary caregiver

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

A Multicenter, Randomized, Controlled Clinical Trial of Attention Reduction Intervention Therapy for Children With Transient Tic Disorder Primarily Characterized by Abnormal Blinking

Acronym: LETITTIC

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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