Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CBIT + rTMS

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

Group Type ACTIVE_COMPARATOR

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type BEHAVIORAL

CBIT is a manualized treatment program focused on tic management skills

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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 + cTBS

Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).

Group Type ACTIVE_COMPARATOR

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type BEHAVIORAL

CBIT is a manualized treatment program focused on tic management skills

Continuous Theta Burst Stimulation (cTBS)

Intervention Type 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 + Sham

Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.

Group Type SHAM_COMPARATOR

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type BEHAVIORAL

CBIT is a manualized treatment program focused on tic management skills

Interventions

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Comprehensive Behavioral Intervention for Tics (CBIT)

CBIT is a manualized treatment program focused on tic management skills

Intervention Type BEHAVIORAL

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No