Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    60
  • sponsor
    University of Minnesota
Updated on 14 July 2022

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.

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.

Details
Condition Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence
Treatment Repetitive Transcranial Magnetic Stimulation (rTMS), continuous theta burst stimulation (cTBS), Comprehensive Behavioral Intervention for Tics (CBIT)
Clinical Study IdentifierNCT04578912
SponsorUniversity of Minnesota
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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