XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders

NCT06348511 | Completed

• 1 other identifier: 0165-22-TLV
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome.

Conditions

Tic Disorders

Outcome Measures

Primary Outcomes (7)

• The Tic Yale Global Tic Severity Scale (YGTSS)

  A semi-structured clinical interview for assessment of tic severity administered to participants and parents. A clinician rates motor and vocal tics in terms of number, frequency, intensity, complexity and interference as well as overall related impairment over the preceding week. The investigators used YGTSS total tic severity scores.

  Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)

• The Parent Tic Questionnaire (PTQ)

  A parent-report instrument for assessing tic severity. Tics are rated by frequency and intensity, and are summed to reflect motor, vocal, and total tics scores. PTQ has good internal consistency, good to excellent 2-week temporal stability, and convergent and discriminant validity in a clinic sample.

  Baseline, after Phase 1, after Phase 2, after the Booster phase (Week 7), and three months after the treatment termination

• Premonitory Urge for Tic Scale (PUTS)

  A self-report scale, which measures tic-related premonitory urges.

  Baseline, after Phase 1, after Phase 2

• The Subjective Units of Distress Scale (SUDS)

  A self-reported questionnaire assessing the degree of inconvenience attributed to (1) tics and (2) the premonitory urges. Participants provided their ratings on a scale ranging from 0 (indicating absence) to 10 (indicating very severe). The total score was computed by summing the responses from both scales.

  By the end of each training day

• The "Urge Thermometer"

  A momentary ratings of the experienced magnitude of premonitory urge. The scale consisted of five qualitative descriptions of "0- not at all", "1 - weak", "2 - medium", "3 - strong" and "4- very strong". The child was instructed to pick a number/description to indicate his/her current pre-tic urge

  By the end of each training day

• Rush Videotape Protocol

  Based on the Rush Videotape Protocol, the investigators recorded the participants under two resting epochs (i.e., performing no specific task) where they were left alone in the room and were instructed to remain seated and wait for 2.5 minutes while avoiding tic suppression. Tics were counted offline by a human rater who also marks epochs in which the participant is hidden or moved in a way that violated the instructions. The investigators used the total Rush scores, which combine scores for tic frequency (number of motor and phonic tics divided by duration of valid recording) and severity of motor and phonic tics.

  Week 1, Week 3, Week 5

• Tic-to-tic interval

  The duration between two subsequent tics

  Week 1, Week 3

Secondary Outcomes (7)

• The Screen for Child Anxiety Related Emotional Disorders (SCARED)

  Week 1, Week 5

• The Children Depression Inventory (CDI)

  Baseline and after Phase 2

• The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)

  Week 1, Week 5

• Obsessive Compulsive Inventory-Child Version (OCI-CV)

  Week 1, Week 5

• The Behavior Rating Inventory of Executive Function (BRIEF)

  Week 1, Week 5

Study Arms (2)

Immediate and contingent reward (ICR)

EXPERIMENTAL

Tic suppression directly affects gameplay, with participants informed that suppressing tics weakens opponents and improves card acquisition. Daily sessions end with feedback on suppression performance relative to that day's baseline.

Device: XTics

Delayed reward (DR)

ACTIVE COMPARATOR

The gameplay does not depend on performance, but participants still receive end-of-session feedback on tic suppression.

Device: XTics

Interventions

XTics DEVICE

XTics is a gamified protocol of behavioral treatment for tic disorders. The participant's tics are monitored in real-time and they are reflected as achievements in a game that the participant plays at the same time. The rewards aim to counteract processes that consolidate the tic. XTics is compatible with ERP treatment, and it includes an introductory psychoeducation session and three behavioral training sessions.

Delayed reward (DR); Immediate and contingent reward (ICR)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and youths aged 7-15 years,
• At least moderate tic severity as indicated by a Yale Global Tic Severity Scale (YGTSS) tic severity score ≥ 11 and
• Tic frequency of over one tic per minute on average in the screening interview.

You may not qualify if:

• Behavioral treatment for tics in the past 12 months
• Pharmacological treatment for tics that has not been stable the for the past 6 weeks or with planned changes during study participation
• Evidence of tics that may produce physical harm to the child
• A history of psychiatric or neurological disorders requiring hospitalisation or a known cognitive decline.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Sagol Brain Institute, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Gal Raz, PhD

  Sagol Brain Institute, Tel Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)