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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04578912
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tic Disorders Tics Tic, Motor Tic Disorder, Childhood Tourette Syndrome Tourette Syndrome in Children Tourette Syndrome in Adolescence Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Continuous Theta Burst Stimulation (cTBS) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CBIT + rTMS
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)
CBIT is a manualized treatment program focused on tic management skills

Device: 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
Active Comparator: CBIT + cTBS
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)
CBIT is a manualized treatment program focused on tic management skills

Device: 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
Sham Comparator: CBIT + Sham
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)
CBIT is a manualized treatment program focused on tic management skills


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578912


Contacts
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Contact: Kerry Houlihan 612-625-8448 canlab@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Christine Conelea, PhD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Christine Conelea, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04578912    
Other Study ID Numbers: PSYCH-2020-29064
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Some datasets (to be determined) will be made available via NIH National Database Archive.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tourette Syndrome
Tics
Tic Disorders
Disease
Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations