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. 2023 Jul 3;24:439. doi: 10.1186/s13063-023-07455-1
Title {1} The CBIT + TMS trial: study protocol for a two-phase randomized controlled trial testing neuromodulation to augment behavior therapy for youth with tics
Trial registration {2a and 2b} ClinicalTrials.gov Identifier: NCT04578912
Protocol version {3}

February 24, 2022

Protocol version 6

Funding {4}

This research is funded by the National Institute of Mental Health of the US National Institutes of Health (R61MH123754, PI: Conelea).

Other resources: This research is supported in part by the Center for Magnetic Resonance Research (NIBIB P41 EB027061 and 1S10OD017974-01 “High Performance Connectome Upgrade for Human 3 T MR Scanner”); Center for Neurobehavioral Development at the Masonic Institute for the Developing Brain, University of Minnesota; and the MnDRIVE Non-invasive Neuromodulation Laboratories, University of Minnesota.

Author details {5a}

C. Conelea: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

D.J. Greene: Department of Cognitive Science, University of California San Diego, USA

J. Alexander: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

K. Houlihan: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

S. Hodapp: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

B. Wellen: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

S. Francis: Department of Psychiatry and Behavioral Sciences, University of Minnesota, USA

B. Mueller: Department of Psychiatry and Behavioral Sciences, University of Minnesota, USA

T. Hendrickson: University of Minnesota Informatics Institute, Masonic Institute for the Developing Brain, USA

A. Tseng: Department of Psychiatry and Behavioral Sciences, Masonic Institute for the Developing Brain, University of Minnesota, USA

M. Chen: Non-invasive Neuromodulation Lab, Brain Conditions, MnDRIVE Initiative, University of Minnesota, USA; Department of Psychiatry and Behavioral Sciences, University of Minnesota, USA; Neuroscience Program, Research Department, Gillette Children’s Specialty Healthcare, USA

M. Fiecas: School of Public Health, Division of Biostatistics, University of Minnesota, USA

K. Lim: Department of Psychiatry and Behavioral Sciences, University of Minnesota, USA

A. Opitz: Department of Biomedical Engineering, University of Minnesota, USA

S. Jacob: Department of Psychiatry and Behavioral Sciences, University of Minnesota, USA

Name and contact information for the trial sponsor {5b}

Investigator-initiated clinical trial

C. Conelea (principal investigator)

Masonic Institute for the Developing Brain

2025 E. River Pkwy, Minneapolis, MN 55414

Role of sponsor {5c} This is an investigator-initiated clinical trial. Therefore, the funders played no role in the design of the study; collection, analysis, and interpretation of the data; and writing of the manuscript.