Ohio State is in the process of revising websites and program materials to accurately reflect compliance with the law. While this work occurs, language referencing protected class status or other activities prohibited by Ohio Senate Bill 1 may still appear in some places. However, all programs and activities are being administered in compliance with federal and state law.

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, the study's Principal Investigator 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);

    • Set the Projected Start Date a minimum of one month after the submission date to allow sufficient time for CCBBI and the safety consultants to carefully review the proposal.
    • A tentative end date must be specified. “Ongoing” is not acceptable.
    • Specify the anticipated number of participants and total number of hours for the study.
    • List one person per line in the Personnel Table. If there are more personnel than the space provided in the application, attached a table listing the additional personnel and their information.
    • Degree should reflect the level of education (BA, BS, MA, PhD, MD) and not position title (PI, RA, GRA, Post-doc)
    • The Certification Level should reflect the current level of certification and not the anticipated certification level.

  • 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 in a table at the beginning of each study aim.
      • Frequency of stimulation
      • Train duration
      • Inter-train interval
      • Total number of pulses per session
      • Total time TMS stimuli will be applied during a 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.