Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

Tourette Syndrome Clinical Trial

Official title:

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578912
• Other study ID #: PSYCH-2020-29064
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	approximately 3-4 months
Secondary	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.	baseline to 3 months post-treatment
Secondary	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.	approximately 3-4 months