Appendix E: CCBBI TMS Study Application

Before initiating any TMS research at the Center for Cognitive and Behavioral Brain Imaging (CCBBI), investigators must obtain approval through two key channels:

  1. Institutional Review Board (IRB) Approval:
    All TMS studies must be reviewed and approved by Ohio State’s Biomedical IRB. The IRB protocol must include a thorough description of the TMS procedures, risk mitigation strategies, and a completed TMS safety screening plan.
  2. CCBBI Steering Committee Approval:
    In addition to IRB approval, investigators must receive approval from the CCBBI Steering Committee. This ensures that the proposed TMS study adheres to the center’s equipment use policies, safety standards, and scheduling procedures.

Studies cannot be scheduled or initiated until both approvals are in place.

Required Documents and Forms

To request approval from CCBBI, investigators must submit the following materials:

  • A copy of the IRB approval letter for the study;

  • A completed Application for TMS Time for Funded Studies Proposal (See Appendix E);

  • A 5-page research proposal, which must include the following four subsections:

    • Brief description of research goals and hypotheses
    • Description of subjects to be tested
    • Specifications of protocol to be employed. In addition to other study details, please include the following details about the TMS protocol.
      • Frequency of stimulation
      • Train duration
      • Inter-train interval
      • Total number of pulses per session
    • Analyses to be performed

Investigators must also indicate the study’s risk classification (Class 1, 2, or 3) and identify whether a covering MD is required. Please refer to Rossi et al. (2009) and Rossi et al. (2021) to determine type of TMS Study. A list of personnel involved in TMS delivery should be provided, along with their certification level (Level 1 or Level 2).

Contact for Submission

Completed applications and required documents should be submitted via email to ccbbi.service@osu.edu. Please include “TMS Study Application” in the subject line. Questions about the application process or study design requirements can also be directed to this email address.