TicsPhase 2NCT06678737
CBIT+TMS R33 Phase
A Phase 2 study testing CBIT +cTBS in people with Tics and Tourette Syndrome, run by University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Tics, Tourette Syndrome
- What is being tested?
- CBIT +cTBS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 15 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-21 years at time of enrollment.
- Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
- At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- Full scale IQ greater than 70.
- Child, consenting parent, and adult participant required to have English fluency and literacy to ensure comprehension of study measures and instructions.
- To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 6 weeks and expect to remain stable for the approximately 3-week intervention protocol (with the exception of those taking neuroleptic/antipsychotic medications). Those who previously received tic-specific therapy will be included if they meet the tic severity criterion.
- 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.
Who cannot join
- Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or girls of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician.
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
- Active suicidality.
- Previous diagnosis of psychosis or cognitive disability.
- Substance abuse or dependence within the past year.
- Concurrent psychotherapy focused on tics.
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- Neuroleptic/antipsychotic medications.
- Pregnant according to the medical history or a urine pregnancy test; and menstruating individuals capable of becoming pregnant and not using a highly effective form of contraception (FDA-approved hormonal contraceptive, IUD, tubal ligation)
- Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Christine Conelea, cconelea@umn.edu
About this study
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.
- Conditions
- Tics, Tourette Syndrome
- Being tested
- CBIT +cTBS, CBIT +sham cTBS
- Medical subject headings
- Tics, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBIT +cTBSOther
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.
CBIT +sham cTBSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: CBIT +cTBS |
| Control group | Sham comparator | Youth with chronic tics randomized to CBIT and sham stimulation for TMS Receives: Other: CBIT +sham cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tic severity
Yale Global Tic Severity Scale, YGTSS: Gold-standard, clinician-administered tic severity scale. Includes symptom checklist of specific tic types.
Measured: 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.
Measured: pretreatment, 10days, 1,3,6 months
Tic symptoms severity
Parent/Adult Tic Questionnaire : Adult-self or parent-report measure of tic symptoms and severity
Measured: pretreatment, 10days, 1,3,6 months
Premonitory Urge for Tics Scale
Self-report measure of intensity of urges to tic
Measured: 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
Measured: pretreatment, 3,6 months
Self- and parent measure of functional impairment
Patient-Reported Outcomes Measurement Information System (PROMIS-49)
Measured: pretreatment, 10days, 1,3,6 months
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.
Measured: pretreatment, 1,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start27 Feb 2025
- Primary completion15 Jul 2030 (estimated)
- Study completion15 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TicsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a double-blinded randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Conelea, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678737
- Sponsor's protocol ID
- R33 phase
- Status last verified
- May 2026
- First submitted
- 31 Oct 2024
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBIT+TMS R33 Phase
- ClinicalTrials.gov ID
- NCT06678737
- Acronym / sponsor ID
- R33 phase
- Conditions
- Tics, Tourette Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 15 Jul 2030 (estimated)
- Study completion
- 15 Jul 2030 (estimated)
- First posted
- 7 Nov 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a double-blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: CBIT +cTBSYouth 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 | Other: CBIT +sham cTBSYouth with chronic tics randomized to CBIT and sham stimulation for TMS |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 12-21 years at time of enrollment.
- Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
- At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- Full scale IQ greater than 70.
- Child, consenting parent, and adult participant required to have English fluency and literacy to ensure comprehension of study measures and instructions.
Key exclusion criteria (9 listed)
- Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or girls of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician.
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
- Active suicidality.
- Previous diagnosis of psychosis or cognitive disability.
- Substance abuse or dependence within the past year.
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 |
|---|---|---|
| CBIT +cTBS10 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. | Other | Experimental group |
| CBIT +sham cTBS10 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. | Other | Control group |
Primary outcome
Tic severity
Time frame: pretreatment, 10days, 1,3,6 months
Yale Global Tic Severity Scale, YGTSS: Gold-standard, clinician-administered tic severity scale. Includes symptom checklist of specific tic types.
Tic Suppression Task
Time frame: pretreatment, 10days, 1,3,6 months
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.
Tic symptoms severity
Time frame: pretreatment, 10days, 1,3,6 months
Parent/Adult Tic Questionnaire : Adult-self or parent-report measure of tic symptoms and severity
Premonitory Urge for Tics Scale
Time frame: pretreatment, 10days, 1,3,6 months
Self-report measure of intensity of urges to tic
Emotional and Behavioral functioning
Time frame: pretreatment, 3,6 months
Child/Adult Behavior Checklist: Parent- or adult-self report measuring broad emotional and behavioral functioning
Self- and parent measure of functional impairment
Time frame: pretreatment, 10days, 1,3,6 months
Patient-Reported Outcomes Measurement Information System (PROMIS-49)
Behavior Rating Inventory of Executive Function
Time frame: pretreatment, 1,3,6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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.
Christine Conelea principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBIT +cTBS in people with Tics and Tourette Syndrome, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Conelea, PhD, LP (612-626-3127, cconelea@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tic severity (time frame: pretreatment, 10days, 1,3,6 months). 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 20 May 2026.