Let It TiC in Childhood Provisional Eye Tic

NCT07838428 | Not Yet Recruiting DMC

• 1 other identifier: LET IT TIC
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tic Disorder; Provisional Tic Disorder

Keywords

tic disorder; provisional tic disorder; behavioral intervention

Outcome Measures

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.

  through study completion, an average of 6 months

Secondary Outcomes (4)

• YGTSS impairment subscale

  through study completion, an average of 6 months

• ocular and systemic Adverse Events (AEs)

  through study completion, an average of 6 months

• Self-Rating Depression Scale(SDS)

  through study completion, an average of 6 months

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

  through study completion, an average of 6 months

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

The behavioral intervention group received the attention reduction intervention therapy.

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.

Other: Continue with the previous treatment plan

Interventions

Reducing Attentional Interventions Therapy Treatment BEHAVIORAL

Reducing Attentional Interventions Therapy Treatment

Behavioral intervention

Continue with the previous treatment plan OTHER

Continue with the previous treatment plan

Control group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, China

Location

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Dan Liang professor

CONTACT

0086-020-87330402; wuhaoeye@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)