search
Back to results

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

Primary Purpose

Tic Disorders, Tics, Tic, Motor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics (CBIT)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous Theta Burst Stimulation (cTBS)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic Disorders

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

CBIT + rTMS

CBIT + cTBS

CBIT + Sham

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 30, 2020
Last Updated
September 18, 2023
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT04578912
Brief Title
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Official Title
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBIT + rTMS
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Arm Title
CBIT + cTBS
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Arm Title
CBIT + Sham
Arm Type
Sham Comparator
Arm Description
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics (CBIT)
Intervention Description
CBIT is a manualized treatment program focused on tic management skills
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
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
Intervention Name(s)
Continuous Theta Burst Stimulation (cTBS)
Intervention Description
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 Outcome Measure Information:
Title
Change in resting state fMRI connectivity of SMA-mediated brain circuits
Description
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).
Time Frame
baseline to post-treatment; approximately 10 days
Title
Change in SMA activation
Description
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).
Time Frame
baseline to post-treatment; approximately 10 days
Secondary Outcome Measure Information:
Title
Safety: Measured as Rate of Adverse Events Related to Study Treatment
Description
The number of adverse events judged to be treatment related will be totaled and reported for each group.
Time Frame
approximately 3-4 months
Title
Change in Tic Suppression Task
Description
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.
Time Frame
baseline to 3 months post-treatment
Title
Feasibility: Measured as Participant Treatment Completion
Description
For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.
Time Frame
approximately 3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Breitenfeldt
Email
breit241@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Conelea, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Conelea, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Some datasets (to be determined) will be made available via NIH National Database Archive.

Learn more about this trial

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

We'll reach out to this number within 24 hrs