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The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS targeting the SMA. The specific type of TMS procedure will be randomly assigned between subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation (cTBS), or sham stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBIT + rTMS | Active Comparator | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS). |
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| CBIT + cTBS | Active Comparator | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS). |
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| CBIT + Sham | Sham Comparator | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Behavioral Intervention for Tics (CBIT) | Behavioral | CBIT is a manualized treatment program focused on tic management skills |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits | For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d). | baseline to post-treatment; approximately 10 days |
| Change in SMA Activation | For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d). | baseline to post-treatment; approximately 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Measured as Rate of Adverse Events Related to Study Treatment | The number of adverse events judged to be treatment related will be totaled and reported for each group. | approximately 3-4 months |
| Change in Tic Suppression Task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Conelea, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37400828 | Derived | Conelea C, Greene DJ, Alexander J, Houlihan K, Hodapp S, Wellen B, Francis S, Mueller B, Hendrickson T, Tseng A, Chen M, Fiecas M, Lim K, Opitz A, Jacob S. The CBIT + TMS trial: study protocol for a two-phase randomized controlled trial testing neuromodulation to augment behavior therapy for youth with chronic tics. Trials. 2023 Jul 3;24(1):439. doi: 10.1186/s13063-023-07455-1. | |
| 37398344 |
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Some datasets (to be determined) will be made available via NIH National Database Archive.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: 1 Hz rTMS | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS). |
| FG001 | Active Comparator: cTBS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2022 |
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| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region |
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| Continuous Theta Burst Stimulation (cTBS) | Device | During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region |
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The Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment.
| baseline to 3 months post-treatment |
| Feasibility: Measured as Participant Treatment Completion | For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group. | approximately 3-4 months |
| Derived |
| Conelea C, Greene D, Alexander J, Houlihan K, Hodapp S, Wellen B, Francis S, Mueller B, Hendrickson T, Tseng A, Chen M, Fiecas M, Lim K, Opitz A, Jacob S. The CBIT+TMS Trial: study protocol for a two-phase randomized controlled trial testing neuromodulation to augment behavior therapy for youth with chronic tics. Res Sq [Preprint]. 2023 Jun 13:rs.3.rs-2949388. doi: 10.21203/rs.3.rs-2949388/v1. |
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
| FG002 | Sham Comparator: Sham | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: 1 Hz rTMS | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS). |
| BG001 | Active Comparator: cTBS | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS). |
| BG002 | Sham Comparator: Sham | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits | For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d). | Posted | Mean | Standard Deviation | eta squared | baseline to post-treatment; approximately 10 days |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Change in SMA Activation | For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d). | Posted | Mean | Standard Deviation | eta squared | baseline to post-treatment; approximately 10 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Safety: Measured as Rate of Adverse Events Related to Study Treatment | The number of adverse events judged to be treatment related will be totaled and reported for each group. | Posted | Number | events | approximately 3-4 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Tic Suppression Task | The Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment. | Posted | Mean | Standard Deviation | tics per minute | baseline to 3 months post-treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Feasibility: Measured as Participant Treatment Completion | For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group. | Posted | Number | participants | approximately 3-4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: 1 Hz rTMS | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS). | 0 | 17 | 0 | 17 | 17 | 17 |
| EG001 | Active Comparator: cTBS | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS). | 0 | 15 | 0 | 15 | 15 | 15 |
| EG002 | Sham Comparator: Sham | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation. | 0 | 16 | 0 | 16 | 14 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Muscle Twitch | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| sleep disturbance | General disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Mood change | General disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Scalp discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Concentration difficulties | General disorders | Non-systematic Assessment |
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| Hearing difficulties | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Conelea | University of Minnesota | (612) 261-3127 | cconelea@umn.edu |
| Feb 16, 2025 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2023 | Dec 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013981 | Tic Disorders |
| D020323 | Tics |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | CBIT + Sham | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills |
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| CBIT + Sham |
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills |
|
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| OG002 | CBIT + Sham | Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills |
|
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| CBIT + Sham |
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills |
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