Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder

NCT06385535 | Recruiting

• 1 other identifier: IRB_00171031
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:

1. 1.See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic
2. 2.See whether the timing of a tic can tell us how well the person can control/stop that tic
3. 3.See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop it
4. 4.During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.
5. 5.During the second visit, the study researcher will treat one of the participant's tics.
6. 6.During the third visit, the study researcher will treat another one of the participant's tics.
7. 7.During the fourth visit, the study researcher will treat another one of the participant's tics.
8. 8.During the fifth visit, the study researcher will treat another one of the participant's tics.
9. 9.During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic.

Conditions

Tics; Tic Disorders; Vocal Tic; Motor Tic; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Tics/Tremor

Keywords

Tics; Tic Disorders; Vocal Tic; Motor Tic; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Tics/Tremor

Outcome Measures

Primary Outcomes (7)

• Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies

  Estimates of individual and total tic fractality at baseline will be obtained using tic time series data (i.e., temporal sequences of the presence or absence of tics) during the three free-to-tic (FTT) and three differential reinforcement of other behavior (DRO) conditions of the reinforced tic suppression task (RTST) administered at baseline (pre-intervention). The degree to which individual and total tic time series' follow the frequency spectrum of pink noise (R\^2i) will be calculated and conditionally aggregated to provide average estimated fractal exponents.

  Pre-intervention (baseline)

• Voluntary tic suppression success at baseline

  Voluntary individual and total tic suppression success will be measured by the average proportion of change of individual and total tic frequency from the three free-to-tic (FTT) and three differential reinforcement of other behavior (DRO) conditions of the reinforced tic suppression task (RTST) administered at baseline. Larger differences between the average number of tics observed during FTT and DRO conditions will indicate greater voluntary suppression success.

  Pre-intervention (baseline)

• Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS)

  The Yale Global Tic Severity Scale (YGTSS) will be used to measure total tic severity at baseline across five dimensions: number, frequency, intensity, complexity, and interference. Scores range from 0-5 (low-high) on each dimension and are totaled to indicate overall severity during the past week. Scores are summed to provide a Total Tic Severity Score ranging from 0-50 (none-severe).

  Pre-intervention (baseline)

• Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ)

  The Parent Tic Questionnaire (PTQ) will be used to characterize individual and total tic severity at baseline. The PTQ assesses for the presence of common motor and vocal tics over the past week. Frequency and intensity scores ranging from 1-4 (low, high) are obtained for each endorsed tic, which can be summed to yield an individual tic severity score ranging from 0-8 (low, high).

  Pre-intervention (baseline)

• Changes in voluntary individual and total tic suppression success pre- and post-intervention

  Voluntary individual and total tic suppression success will be measured by the average proportion of change of individual and total tic frequency from the three free-to-tic (FTT) and three differential reinforcement of other behavior (DRO) conditions of the reinforced tic suppression tasks (RTSTs) administered at baseline and post-treatment. Larger differences between the average number of tics observed during FTT and DRO conditions at individual time points will indicate greater voluntary suppression success. Larger differences between estimates of suppression success before and after HRT will indicate greater changes in suppression abilities following treatment.

  Pre-intervention (baseline), up to 1 week post intervention

• Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention

  Estimates of individual and total tic fractality at baseline and post-intervention will be obtained using tic time series data (i.e., temporal sequences of the presence or absence of tics) during the three free-to-tic (FTT) and three differential reinforcement of other behavior (DRO) conditions of the reinforced tic suppression task (RTST) administered at baseline (pre-intervention) and post-intervention, respectively. The degree to which individual and total tic time series' follow the frequency spectrum of pink noise (R\^2i) will be calculated and conditionally aggregated to provide average estimated fractal exponents at individual time points. Larger differences between fractal exponents before and after HRT will indicate greater changes in tic fractality following treatment.

  Pre-intervention (baseline), up to 1 week post intervention

• Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ)

  The Yale Global Tic Severity Scale (YGTSS) measures total tic severity across five dimensions: number, frequency, intensity, complexity, and interference. Scores range from 0-5 (low-high) on each dimension and are totaled to indicate overall severity during the past week. Scores are summed to provide a Total Tic Severity Score ranging from 0-50 (none-severe). The Parent Tic Questionnaire (PTQ) measures individual and total tic severity by assessing for the presence of common motor and vocal tics over the past week. Frequency and intensity scores ranging from 1-4 (low, high) are obtained for each endorsed tic, which can be summed to yield an individual tic severity score ranging from 0-8 (low, high). The YGTSS and PTQ will be used to measure total and individual and total tic severity, respectively, at baseline and post-intervention. Larger differences between YGTSS and PTQ scores before and after HRT will indicate greater changes in tic severity following treatment.

  Pre-intervention (baseline), up to 1 week post intervention

Secondary Outcomes (7)

• Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)

  Pre-intervention (baseline)

• Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)

  Up to 1 week post intervention

• Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)

  Pre-intervention (baseline), up to 1 week post intervention

• Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS)

  Up to 1 week post intervention

• Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ)

  Up to 1 week post intervention

Study Arms (1)

Habit Reversal Training (HRT)

EXPERIMENTAL

All participants receive 4 sessions of HRT (Habit Reversal Training) to treat their tics.

Behavioral: Habit Reversal Training (HRT)

Interventions

Habit Reversal Training (HRT) BEHAVIORAL

Habit Reversal Training (HRT) is a multicomponent treatment package developed to treat a repetitive behaviors. HRT includes (1) increasing awareness of discrete occurrences of tics and associated premonitory urges (PMUs; i.e., awareness training), (2) teaching the patient to suppress tics by engaging in behaviors that are physically incompatible with target tics (i.e., competing response \[CR\] training), and (3) prompting and reinforcing between-session patient engagement with therapeutic techniques and homework (i.e., providing social support).

Also known as: Therapy, Behavior Therapy, Comprehensive Behavioral Intervention for Tics, CBIT, Habit Reversal Therapy, HRT, Tic Therapy

Habit Reversal Training (HRT)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 12 years old child who meets the criteria for diagnosis of a persistent tic disorder (e.g., persistent motor/vocal tic disorder or Tourette's disorder; i.e., engages in motor and/or vocal tics that have been present for at least one year)
• The child's tics initially onset before age 10.
• The child currently engages in at least four different motor and/or vocal tics per minute, on average, during a 10-minute observation period.
• The child has a minimum Total Tic Severity Score of 20 on the Yale Global Tic Severity Scale (10 for motor or vocal tics only)
• If the child is on tic-suppressing or psychotropic medication, the dose has been stable for at least 6 weeks with no changes or planned changes in medication status during the study period.
• Parent and child read and speak fluent English.
• The parent is 18+ years of age.
• Access to a private computer with high-speed internet access and private setting.

You may not qualify if:

• If, based on the assessment of the study investigators, the child has any serious psychiatric or neurological condition that would interfere with study participation (e.g., unmanaged attention-deficit hyperactivity disorder)
• The child has a self- or parent-reported history of, or is reasonably suspected to have or meet criteria for, functional neurological symptom disorder.
• The child has received more than two sessions of behavioral treatment for tics for which tic suppression was a primary component.
• The child has a Total Tic Severity Score of 40+ on the Yale Global Tic Severity Scale (20+ for motor/vocal tics only).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (7)

• Woods DW, Himle MB. Creating tic suppression: comparing the effects of verbal instruction to differential reinforcement. J Appl Behav Anal. 2004 Fall;37(3):417-20. doi: 10.1901/jaba.2004.37-417.

  PMID: 15529900 BACKGROUND

• Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.

  PMID: 2768151 BACKGROUND

• McGuire JF, McBride N, Piacentini J, Johnco C, Lewin AB, Murphy TK, Storch EA. The premonitory urge revisited: An individualized premonitory urge for tics scale. J Psychiatr Res. 2016 Dec;83:176-183. doi: 10.1016/j.jpsychires.2016.09.007. Epub 2016 Sep 9.

  PMID: 27643476 BACKGROUND

• Storch EA, Murphy TK, Geffken GR, Sajid M, Allen P, Roberti JW, Goodman WK. Reliability and validity of the Yale Global Tic Severity Scale. Psychol Assess. 2005 Dec;17(4):486-91. doi: 10.1037/1040-3590.17.4.486.

  PMID: 16393016 BACKGROUND

• Azrin NH, Nunn RG. Habit-reversal: a method of eliminating nervous habits and tics. Behav Res Ther. 1973 Nov;11(4):619-28. doi: 10.1016/0005-7967(73)90119-8. No abstract available.

  PMID: 4777653 BACKGROUND

• Miltenberger RG, Fuqua RW. A comparison of contingent vs non-contingent competing response practice in the treatment of nervous habits. J Behav Ther Exp Psychiatry. 1985 Sep;16(3):195-200. doi: 10.1016/0005-7916(85)90063-1.

  PMID: 4066967 BACKGROUND

• Chang S, Himle MB, Tucker BTP, Woods DW, Piacentini J. Initial psychometric properties of a brief parent-reported instrument for assessing tic severity in children with chronic tic disorders. Child & Family Behavior Therapy. 2009;31:181-191.

  BACKGROUND

MeSH Terms

Conditions

Tics; Tic Disorders; Tourette Syndrome

Interventions

Therapeutics; Behavior Therapy

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Himle, PhD

  University of Utah

  STUDY CHAIR

Central Study Contacts

Kirsten Bootes, MS

CONTACT

801-585-7114; kirsten.bootes@psych.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Principal Investigator and Outcomes Assessors will be blinded to the fractal properties of participants' tics until all study procedures have been completed.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology Doctoral Candidate

Model Details: Clinical trial with a single arm (i.e., participants are not assigned to groups).

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: April 26, 2024
• Study Start: April 4, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication.
• Access Criteria: Qualified researchers are those considered to have academic interests in tic disorders and related conditions, expertise in the scoring and interpretation of the outcome measures administered, and a reasonable and scientifically-sound justification for obtaining participant data.

Locations

US (1)