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

T

Tel Aviv Sourasky Medical Center

Status

Completed

Conditions

Tic Disorders

Treatments

Device: XTics

Study type

Interventional

Funder types

Other

Identifiers

NCT06348511
0165-22-TLV

Details and patient eligibility

About

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.

Full description

Background: Behavioral treatments are recommended as first-line interventions for tic disorders (TDs) in children and adults, which affect 2.99% of children. However, the effectiveness of these interventions is often undermined by the limited compliance especially of young individuals with the demanding treatment protocols. Addressing this issue, gamification of the treatment can enhance engagement and adherence in children. In the context of TDs, gamification provides significant additional benefits, particularly robust immediate feedback. This feedback can counteract the negative reinforcement processes, wherein the tic, believed to relieve the unpleasant premonitory urge, becomes consolidated. The investigators developed a gamified Protocol XTics, which leverages the previously untapped potential of combining various tic triggers with immediate reinforcement of tic suppression. The investigators evaluated the clinical value of XTics, focusing particularly on the benefits of immediate reward contingency in enhancing tic suppression performance.

Methods: The investigators developed a game incorporating tic triggers validated in a prior study. In one version of the game, its progression was influenced by real-time input from an experimenter who continuously monitored the participant's tics, rewarding tic suppression with favorable game outcomes. Employing a crossover design, the investigators trained 35 participants, aged 7-15, in both this version and another where the game's progression was independent of tic suppression. Following two online group Exposure and Response Prevention (ERP) training sessions, each participant engaged in three hourly sessions for each of the two conditions. Our evaluation focused on how the overall XTics protocol influenced tics and how this influence differed between the contingent and non-contingent versions of the game.

Enrollment

35 patients

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

35 participants in 2 patient groups

Immediate and contingent reward (ICR)
Experimental group
Description:
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.
Treatment:
Device: XTics
Delayed reward (DR)
Active Comparator group
Description:
The gameplay does not depend on performance, but participants still receive end-of-session feedback on tic suppression.
Treatment:
Device: XTics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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