Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

NCT04578912 | Completed Results DMC FDA Device

• 1 other identifier: PSYCH-2020-29064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 people with tic disorder. The study will also examine different TMS dosing strategies.

Conditions

Tic Disorders; Tics; Tic, Motor; Tic Disorder, Childhood; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Safety: Measured as Rate of Adverse Events Related to Study Treatment

  approximately 3-4 months

• Change in Tic Suppression Task

  baseline to 3 months post-treatment

• Feasibility: Measured as Participant Treatment Completion

  approximately 3-4 months

Study Arms (3)

CBIT + rTMS

ACTIVE COMPARATOR

Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).

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).

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.

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT) BEHAVIORAL

CBIT is a manualized treatment program focused on tic management skills

CBIT + Sham; CBIT + cTBS; CBIT + rTMS

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

CBIT + rTMS

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

CBIT + cTBS

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• 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.

  PMID: 37400828 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.

  PMID: 37398344 DERIVED

MeSH Terms

Conditions

Tic Disorders; Tics; Tourette Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Christine Conelea
• Organization: University of Minnesota

cconelea@umn.edu

(612) 261-3127

Study Officials

• Christine Conelea, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)