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Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth 1 and are associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, peer victimization, and a fourfold increased risk of suicide compared to the general population. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients. However, in these trials, only 52% of children and 38% of adults showed clinically meaningful tic improvement, meaning that 50-60% of patients do not benefit from CBIT. CBIT success relies on an ability to suppress tics that many youth lack. The central aim of CBIT is to enhance voluntary tic suppression. Better tic suppression ability drives CBIT improvement 10 and predicts lower tic burden over the course of illness. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. However, research shows that many youth lack this fundamental tic suppression ability that CBIT aspires to enhance.
This study will examine the clinical and neural effects of a treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA) in young people with tic disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Youth with chronic tics randomized to a combined treatment involving Comprehensive Behavioral Intervention for Tics (CBIT) and inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS). TMS involves theta burst stimulation (cTBS). |
|
| Control group | Sham Comparator | Youth with chronic tics randomized to CBIT and sham stimulation for TMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBIT +cTBS | Other | 10 daily sessions of CBIT plus cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tic severity | Yale Global Tic Severity Scale, YGTSS: Gold-standard, clinician-administered tic severity scale. Includes symptom checklist of specific tic types. | pretreatment, 10days, 1,3,6 months |
| Tic Suppression Task | Direct observation measure of tic suppression ability. In this paradigm, a participant is seated alone in a room in front of a computer capturing a video recording of tic occurrences for later coding by independent raters. TST will consist of two 3-min conditions: 1) free-to-tic (FT): youth is instructed to stay seated and tic freely, a measure of naturally occurring tic frequency (tics per minute); 2) suppression: youth is instructed to suppress tics. Videos will be coded to establish tic frequencies using a computerized behavioral coding program. | pretreatment, 10days, 1,3,6 months |
| Tic symptoms severity | Parent/Adult Tic Questionnaire : Adult-self or parent-report measure of tic symptoms and severity | pretreatment, 10days, 1,3,6 months |
| Premonitory Urge for Tics Scale | Self-report measure of intensity of urges to tic | pretreatment, 10days, 1,3,6 months |
| Emotional and Behavioral functioning | Child/Adult Behavior Checklist: Parent- or adult-self report measuring broad emotional and behavioral functioning | pretreatment, 3,6 months |
| Self- and parent measure of functional impairment | Patient-Reported Outcomes Measurement Information System (PROMIS-49) | pretreatment, 10days, 1,3,6 months |
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Inclusion Criteria:
Youth receiving other forms of psychotherapy will be included provided these treatments are not focused on tics. All concurrent treatments will be monitored during the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Conelea, PhD, LP | Contact | 612-626-3127 | cconelea@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christine Conelea | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D020323 | Tics |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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The study is a double-blinded randomized control trial
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| CBIT +sham cTBS | Other | 10 daily sessions of CBIT plus sham cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups. |
|
| Behavior Rating Inventory of Executive Function | Self- and parent-rated measure of impairment of executive function. Raw scores are converted into standardized T-scores with a mean of 50 and standard deviation of 10, higher scores reflect greater symptom severity. | pretreatment, 1,3,6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |