Tic DisordersNCT06348511
XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
A study testing XTics in people with Tic Disorders, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Tic Disorders
- What is being tested?
- XTics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Tic Disorders
- Being tested
- XTics
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTicsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: XTics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 1, Week 3, Week 5
Tic-to-tic interval
The duration between two subsequent tics
Measured: Week 1, Week 3
Secondary outcomes (7)
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
A self-report measure for screening anxiety disorders in children. Participants' ratings of their feelings over the previous two weeks are summed into scales of specific anxieties and general anxiety level. SCARED total score is used as a measure of anxiety symptoms. It was filled out by the child with the help of a parent.
Measured: Week 1, Week 5
The Children Depression Inventory (CDI)
A commonly used self-report measure considered useful for screening comorbid depressive disorder in patients with TS (Snijders AH, Robertson MM, Orth M, 2006). The CDI total score is used as a measure of depression symptoms. It is filled out with the child. The investigators used five subscales: Negative Mood, Ineffectiveness, Anhedonia, Negative Self-Esteem, and Interpersonal Problems, as well as the global score.
Measured: Baseline and after Phase 2
The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)
The investigators used the long version, which contains 80 items and estimates different aspects of attention deficit and focus our analysis on the subscales of hyperactivity, inattention, and impulsivity and the composite of ADHD scores. It was filled out by parents or caregivers.
Measured: Week 1, Week 5
Obsessive Compulsive Inventory-Child Version (OCI-CV)
OCI-CV estimates OCD severity across six domains of symptoms: Doubting/Checking, Obsessing, Hoarding, Washing, Ordering, Neutralizing. The total score was computed by summing the responses from all scales. It is filled out with the child. The investigatorslimited our analysis to Doubting/Checking, Obsessing, and total scores.
Measured: Week 1, Week 5
The Behavior Rating Inventory of Executive Function (BRIEF)
BRIEF evaluates children's everyday executive functioning skills. Based on responses to 86 questions, executive functions are assessed across eight domains. The investigators used the composite Behavioral Regulation Index (BRI), which combines the Inhibit, Shift, and Emotional Control subdomains, the Metacognition Index (MI), which combines the subdomains of Organization of Materials and Monitor, and the overall Global Executive Composite (GEC) index, which combines the BRI and MI. BRIEF is filled out by the parents.
Measured: Week 1, Week 5
The Emotion Regulation Questionnaire (ERQ)
A 10-item scale evaluating the respondents' tendency to regulate their emotions by cognitive Reappraisal or by expressive suppression. It was filled out by the child with the help of a parent.
Measured: Week 1, Week 5
User Engagement Scale (UES)
The short Hebrew version of the UES is administered in regard to the game version they played in the past week. In this 12-item questionnaire, four different aspects of the user's experience are estimated using a five-point rating scale:(i) Focused attention, estimating the extent to which the user felt absorbed in the interaction and lost track of time; (ii) Perceived usability, indicating negative affect experienced as a result of the interaction and the degree of control and effort expended; (iii) Aesthetic appeal, i.e., the attractiveness and visual appeal of the interface; (iv) Reward factor, the extent to which the user felt that the experience was satisfying and interesting. The investigators used a composite index, which sums up the scores of UES scales.
Measured: Week 3, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic DisordersStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gal Raz, PhD, Principal investigator, Sagol Brain Institute, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348511
- Sponsor's protocol ID
- 0165-22-TLV
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
- ClinicalTrials.gov ID
- NCT06348511
- Acronym / sponsor ID
- 0165-22-TLV
- Conditions
- Tic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate and contingent reward (ICR) | Experimental | Device: XTicsTic 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. |
| Delayed reward (DR) | Active comparator | Device: XTicsThe gameplay does not depend on performance, but participants still receive end-of-session feedback on tic suppression. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTicsXTics 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. | Device | Delayed reward (DR), Immediate and contingent reward (ICR) |
Primary outcome
The Tic Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)
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.
The Parent Tic Questionnaire (PTQ)
Time frame: Baseline, after Phase 1, after Phase 2, after the Booster phase (Week 7), and three months after the treatment termination
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.
Premonitory Urge for Tic Scale (PUTS)
Time frame: Baseline, after Phase 1, after Phase 2
A self-report scale, which measures tic-related premonitory urges.
The Subjective Units of Distress Scale (SUDS)
Time frame: By the end of each training day
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.
The "Urge Thermometer"
Time frame: By the end of each training day
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
Rush Videotape Protocol
Time frame: Week 1, Week 3, Week 5
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.
Tic-to-tic interval
Time frame: Week 1, Week 3
The duration between two subsequent tics
7 secondary outcomes
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Week 1, Week 5
The Children Depression Inventory (CDI)
Time frame: Baseline and after Phase 2
The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)
Time frame: Week 1, Week 5
Obsessive Compulsive Inventory-Child Version (OCI-CV)
Time frame: Week 1, Week 5
The Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Week 1, Week 5
The Emotion Regulation Questionnaire (ERQ)
Time frame: Week 1, Week 5
User Engagement Scale (UES)
Time frame: Week 3, Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Raz, PhD principal investigator
Sagol Brain Institute, Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XTics in people with Tic Disorders, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Tic Yale Global Tic Severity Scale (YGTSS) (time frame: Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.