Concurrent TMS and EEG Pilot Study

NCT05665634 | Completed

• 1 other identifier: IRB00233571
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the test-retest reliability of transcranial magnetic stimulation (TMS) -evoked potentials (TEPs) as measured by electroencephalography (EEG), using three different TMS protocols over five different brain regions in healthy volunteers. The goal is to compare the test-retest reliability of single pulse, inhibitory and excitatory TMS protocols as well as two distinct targeting approaches. The main questions to answer are:

1. 1.This study will investigate whether the test-retest reliability of TEPs differ across TMS protocols.
2. 2.This study will investigate whether the test-retest reliability of TEPs differ between individualized and non-individualized targeting approaches.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Comparison of interclass correlation coefficients (ICC) of TMS Evoked Potential amplitudes, as measured by EEG, between single and paired-pulse TMS protocols

  TMS evoked potentials (TEP) during single and paired-pulse protocols will be measured by simultaneous EEG recording. TEP amplitudes at approximately 40, 60, 100 and 200 ms will be calculated per subject, individualized brain region (anatomically based M1, connectivity based DLPFC and angular gyrus), TMS protocol and session. ICCs will be calculated across sessions and subjects per TEP for each individualized brain region and TMS protocol. ICCs per brain region will be compared between single and paired-pulse TMS protocols.

  Session 1 and session 2 with one week between sessions

• Comparison of interclass correlation coefficients (ICC) of TMS Evoked Potential amplitudes, as measured by EEG, between individualized and non-individualized targeting approaches

  TMS evoked potentials (TEP) during single pulse TMS protocols will be measured by simultaneous EEG recording. TEP amplitudes at approximately 40, 60, 100 and 200 ms will be calculated per subject, individualized and non-individualized (connectivity-based vs literature-based DLPFC and angular gyrus) brain region and session. ICCs will be calculated across sessions and subjects per TEP for all brain regions (connectivity-based vs literature-based DLPFC and angular gyrus) that were targeted by single-pulse protocols. ICCs will be compared between individualized and non-individualized targeting approaches.

  Session 1 and session 2 with one week between sessions

Study Arms (1)

All participants

EXPERIMENTAL

Device: Concurrent transcranial magnetic stimulation and electroencephalogram

Interventions

Concurrent transcranial magnetic stimulation and electroencephalogram DEVICE

Single and paired-pulse TMS will be applied to 5 different brain regions during simultaneous recording of EEG. Paired-pulse stimulations will have either 3 ms or 11 ms between pulses, to stimulate cortical inhibition and excitation respectively. Stimulation intensity for single-pulse stimulation blocks will be 120% of the resting motor threshold (RMT). For paired-pulse blocks, the conditioning (first) pulse will be delivered at a stimulation intensity of 80% RMT, and the test (second) pulse will be delivered at 120% RMT. Each test block will consist of 60 TMS trials and will last for 5 minutes. Order of test blocks will be pseudo-randomized across participants. Out of 5 stimulation sites, 3 will be determined based on individual's own brain anatomy and resting state connectivity. These 3 regions will be stimulated using all 3 TMS protocols. The other two regions will be determined based on the literature and only be targeted using the single pulse TMS protocol.

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically and psychiatrically healthy
• Between the ages of 18 and 65 years old
• Fluent in English and capable of providing informed consent
• Willing to remove any jewelry, hair clips, bobby pins, or any other potentially conducting or magnetic objects worn on or near the head

You may not qualify if:

• Weight greater than 350 lbs (the weight limit of the specialized TMS/EEG chair)
• Current serious medical or psychiatric illness, or recent heart disease
• Acute intoxication with any drug of abuse, including alcohol or cannabis
• Pregnancy
• History of neurological problems, including epilepsy, seizures, syncope, tinnitus, migraine, or frequent non-migraine (e.g. tension) headaches
• History of head trauma associated with loss of consciousness
• Language or hearing impairment that would undermine communication regarding consent, study procedures, and overall volunteer safety.
• Irritable skin
• For those undergoing MRI procedures in the current study: Any standard MRI contraindication (including implanted medical devices, metal in the body, or claustrophobia incompatible with MRI procedures)
• TMS-contraindicated medical devices, including cochlear implants, pacemaker, neurosensory stimulator, implantable defibrillator, insulin pump, clips, stents, or shunts that may be disrupted by or interact with TMS coil operation
• Taking medications that lower seizure threshold (see Appendix A: List of Contraindicated Medications)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Fred Barrett

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject design. Each participant will undergo the same TMS/EEG procedures twice with one week in between sessions.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 27, 2022
• Study Start: December 2, 2022
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)