The CBIT+TMS Trial: study protocol for a two-phase randomized controlled trial testing neuromodulation to augment...

Area of Science:

• Neuroscience
• Clinical Psychology
• Neuromodulation

Background:

• Comprehensive Behavioral Intervention for Tics (CBIT) is a primary treatment for tic disorders, yet its efficacy is limited to about 50% of patients.
• The supplementary motor area (SMA) is crucial for motor inhibition, and its dysfunction is implicated in tic generation.
• Targeted neuromodulation of the SMA using transcranial magnetic stimulation (TMS) presents a potential strategy to augment CBIT effectiveness.

Approach:

• The CBIT+TMS trial is a two-phase randomized controlled trial evaluating TMS augmentation of CBIT in youth (12-21 years) with chronic tics.
• Phase 1 compares two repetitive TMS (rTMS) protocols (1Hz rTMS vs. continuous theta-burst stimulation [cTBS]) against a sham condition to identify the optimal regimen.
• Phase 2 will compare the selected optimal rTMS regimen against sham, assessing its impact on SMA-mediated circuits and tic controllability, while exploring neural and behavioral mechanisms.

Key Points:

• This trial is among the first to examine TMS augmentation of behavioral therapy in a pediatric population.
• The study will determine if TMS can improve patients' ability to implement tic control strategies learned in CBIT.
• Investigating the link between neural target engagement and clinical outcomes is a primary objective.

Conclusions:

• Results will offer insights into the viability of TMS as an adjunct therapy for enhancing CBIT efficacy in tic disorders.
• The findings may elucidate the neural and behavioral mechanisms underlying treatment response.
• This research could pave the way for novel therapeutic approaches for individuals with tic disorders.