Combined CBIT and rTMS to Improve Tourette's Syndrome

NCT04795908 | Completed Results DMC FDA Device

• 2 other identifiers: IRB202002701-AOCR40702
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome. Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the primary outcome measure. Secondary outcome measures including underlying physiological effects will be measured via functional magnetic resonance imaginge (fMRI), high-density electroencephalograhy (HD-EEG), and TMS.

Conditions

Tourette Syndrome

Keywords

TMS; Transcranial magnetic stimulation; CBIT; Comprehensive Behavioral Intervention for Tics; Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Tic Severity

  Tic severity will be measured with YGTSS. YGTSS is a clinician-rated scale used to assess tic severity, scored out of 100 where a higher score indicates greater tic frequency and severity. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics - scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from 0 to 50.

  Through study completion, an average of 3 months

Secondary Outcomes (7)

• Modified Rush Videotape Tic Rating Scale (mRVTRS)

  Through study completion, an average of 3 months

• Beck Depression Inventory (BDI)

  Through study completion, an average of 3 months

• Beck Anxiety Inventory (BAI)

  Through study completion, an average of 3 months

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Through study completion, an average of 3 months

• Adult ADHD Self-Report Scale (ASRS)

  Through study completion, an average of 3 months

Study Arms (1)

Active rTMS Group

EXPERIMENTAL

Patients will be seated in a comfortable reclined chair. The neurostimulation protocol will include 1-Hz rTMS over the bilateral SMA at 110% resting motor threshold (RMT). The SMA will be identified as 4 cm anterior to the vertex (Cz in standard 10-20 EEG setup). Each session will consist of 6 trains lasting 5 minutes each (300 pulses per train) with an intertrain interval of 1 minute for a total duration of 35 minutes (1800 pulses). Patients will receive 4 sessions each day on 4 consecutive days for a total of 16 sessions. Daily duration of this study protocol should last approximately 170 minutes including a 10 minute break in between each session.

Device: Transcranial Magnetic Stimulation; Behavioral: Comprehensive behavioral intervention

Interventions

Transcranial Magnetic Stimulation DEVICE

rTMS will be delivered using a MagStim Super Rapid2 TMS therapy system.

Active rTMS Group

Comprehensive behavioral intervention BEHAVIORAL

Patients will receive CBIT with a therapist trained in CBIT. Each session will last about an hour and will be delivered remotely via telemedicine. Sessions will be tailed to the patient's individual needs.

Active rTMS Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient diagnosed with Tourette Syndrome \> 18 years of age with moderate tic severity.
• Participants will be allowed to continue oral medications that they are taking for TS concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study

You may not qualify if:

• Presence of metallic objects or neurostimulators in the brain
• Pregnancy
• History of active seizures or epilepsy
• Contraindications to receiving fMRI, such as claustrophobia
• Inability to participate in CBIT due to other underlying cognitive or medical condition

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Fixel Neurologic Institute

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Jessica Frey
• Organization: West Virginia University

jessica.frey@hsc.wvu.edu

304-598-6127

Study Officials

• Aparna Wagle Shukla, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: December 17, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: April 30, 2024
• Results First Posted: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)