Let It TiC in Childhood Provisional Eye Tic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Reducing Attentional Interventions Therapy Treatment
BehavioralReducing Attentional Interventions Therapy Treatment
Continue with the previous treatment plan
Other interventionContinue with the previous treatment plan
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Behavioral interventionExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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