NCT04578912

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-10-08
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study