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Completed

NCT Number: NCT04578912

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

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.

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Key information

Conditions

Tic Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tic Disorder, Childhood Tic, Motor Tics Tourette Syndrome Tourette Syndrome in Adolescence Tourette Syndrome in Children

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Comprehensive Behavioral Intervention for Tics (CBIT)

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

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

    Time frame: approximately 3-4 months

    The number of adverse events judged to be treatment related will be totaled and reported for each group.

  2. Change in Tic Suppression Task

    Time frame: baseline to 3 months post-treatment

    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.

  3. Feasibility: Measured as Participant Treatment Completion

    Time frame: approximately 3-4 months

    For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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