Tic DisordersNCT04578912

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

A study testing Comprehensive Behavioral Intervention for Tics (CBIT), Repetitive Transcranial Magnetic Stimulation (rTMS) and Continuous Theta Burst Stimulation (cTBS) in people with Tic Disorders and Tics, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Tic Disorders, Tics, Tic, Motor
What is being tested?: Comprehensive Behavioral Intervention for Tics (CBIT), Repetitive Transcranial Magnetic Stimulation (rTMS) and Continuous Theta Burst Stimulation (cTBS)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2020to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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 or equal to 70
English fluency to ensure comprehension of study measures and instructions.
Right-handed

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 participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
Inability to undergo MRI.
Left handedness.
Active suicidality.
Previous diagnosis of psychosis or cognitive disability.
Substance abuse or dependence within the past year.

Show all 9Show fewer

Concurrent psychotherapy focused on tics.
Neuroleptic/antipsychotic medications.
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.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children
Being tested: Comprehensive Behavioral Intervention for Tics (CBIT), Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta Burst Stimulation (cTBS)
Medical subject headings: Tic Disorders, Tics, Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comprehensive Behavioral Intervention for Tics (CBIT)Behavioural
CBIT is a manualized treatment program focused on tic management skills
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
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

Study groups in NCT04578912
Study group	Role	What they receive
CBIT + rTMS	Active comparator	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS). Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
CBIT + cTBS	Active comparator	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS). Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Device: Continuous Theta Burst Stimulation (cTBS)
CBIT + Sham	Sham comparator	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment. Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: baseline to post-treatment; approximately 10 days

Secondary outcomes (3)

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.
Measured: approximately 3-4 months
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.
Measured: 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.
Measured: approximately 3-4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202031 Dec 2023

First posted8 Oct 2020
Study start1 Nov 2020
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Tic DisordersStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04578912
Sponsor's protocol ID: PSYCH-2020-29064
Status last verified: Feb 2025
First submitted: 30 Sep 2020
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Some datasets (to be determined) will be made available via NIH National Database Archive.

Publications

Conelea CA, Kretsch S, Greene DJ, Mueller BA, Breitenfeldt C, Houlihan K, Wellen B, Hendrickson T, Alexander J, Fiecas M, Cui E, Duffy K, Schneck D, Chen M, Lewis CP, Roediger D, Opitz A, Jacob S, Lim K. 1Hz vs. cTBS Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: A Randomized Clinical Trial. medRxiv [Preprint]. 2026 Oct 1:2026.09.29.26364036. doi: 10.64898/2026.09.29.26364036.
PubMed 42856611
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.
PubMed 37400828
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.
PubMed 37398344

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tic Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
ClinicalTrials.gov ID: NCT04578912
Acronym / sponsor ID: PSYCH-2020-29064
Conditions: Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 1 Nov 2020 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 8 Oct 2020 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CBIT + rTMS	Active comparator	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
CBIT + cTBS	Active comparator	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Device: Continuous Theta Burst Stimulation (cTBS)Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
CBIT + Sham	Sham comparator	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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 or equal to 70
English fluency to ensure comprehension of study measures and instructions.
Right-handed

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 participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
Inability to undergo MRI.
Left handedness.
Active suicidality.
Previous diagnosis of psychosis or cognitive disability.

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
Comprehensive Behavioral Intervention for Tics (CBIT)CBIT is a manualized treatment program focused on tic management skills	Behavioural	CBIT + Sham, CBIT + cTBS, CBIT + rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS)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	Device	CBIT + rTMS
Continuous Theta Burst Stimulation (cTBS)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	Device	CBIT + cTBS

Primary outcome

Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
Time frame: baseline to post-treatment; approximately 10 days
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).
Change in SMA Activation
Time frame: baseline to post-treatment; approximately 10 days
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).

3 secondary outcomes

Safety: Measured as Rate of Adverse Events Related to Study Treatment
Time frame: approximately 3-4 months
Change in Tic Suppression Task
Time frame: baseline to 3 months post-treatment
Feasibility: Measured as Participant Treatment Completion
Time frame: approximately 3-4 months

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator: 1 Hz rTMS	17	17
Active Comparator: cTBS	16	15
Sham Comparator: Sham	17	16

Primary outcome: Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits

Time frame: baseline to post-treatment; approximately 10 days. Mean (Standard Deviation). Unit: eta squared

Measure	CBIT + rTMS n = 15	CBIT + cTBS n = 13	CBIT + Sham n = 17
Value	0.0312 (0.05)	0.261 (0.05)	0.158 (0.03)

Primary outcome: Change in SMA Activation

Time frame: baseline to post-treatment; approximately 10 days. Mean (Standard Deviation). Unit: eta squared

Measure	CBIT + rTMS n = 15	CBIT + cTBS n = 13	CBIT + Sham n = 17
Value	0.45 (1.25)	0.01 (1.25)	0.27 (1.3)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator: 1 Hz rTMS	0 of 17 (0%)	17 of 17 (100%)	0 of 17
Active Comparator: cTBS	0 of 15 (0%)	15 of 15 (100%)	0 of 15
Sham Comparator: Sham	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42856611Conelea CA, Kretsch S, Greene DJ, Mueller BA, Breitenfeldt C, Houlihan K, Wellen B, Hendrickson T, Alexander J, Fiecas M, Cui E, Duffy K, Schneck D, Chen M, Lewis CP, Roediger D, Opitz A, Jacob S, Lim K. 1Hz vs. cTBS Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: A Randomized Clinical Trial. medRxiv [Preprint]. 2026 Oct 1:2026.09.29.26364036. doi: 10.64898/2026.09.29.26364036.
Derived from this study: PubMed 37400828Conelea 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.
Derived from this study: PubMed 37398344Conelea 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.
Individual participant dataSharing planned: Yes. Some datasets (to be determined) will be made available via NIH National Database Archive.

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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.

Christine Conelea, PhD 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?

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 5 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: finished, as of the sponsor's last update on 7 Mar 2025. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits (time frame: baseline to post-treatment; approximately 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578912, which also lists 3 linked publications.

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 7 Mar 2025.