HealthyNCT05665634
Concurrent TMS and EEG Pilot Study
A study testing Concurrent transcranial magnetic stimulation and electroencephalogram in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Concurrent transcranial magnetic stimulation and electroencephalogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Stimulation and Electroencephalography Pilot Study
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:
- This study will investigate whether the test-retest reliability of TEPs differ across TMS protocols.
- This study will investigate whether the test-retest reliability of TEPs differ between individualized and non-individualized targeting approaches.
Read the detailed description
Participants will first undergo functional magnetic resonance imaging (fMRI) scanning where structural and resting-state functional images will be obtained. In two separate sessions, participants will attend two concurrent TMS/EEG session with one week in between.
During the TMS/EEG sessions, an EEG cap will be placed on the participant's head and the resting motor threshold will be obtained to calibrate the TMS intensity required for the stimulation of target regions. Once setup procedures are complete, eleven total blocks of TMS with simultaneous EEG recording will take place. Among eleven blocks, five of will use single-pulse stimulation (to stimulate cortical excitation), three will use paired-pulse stimulation with 3ms between pulses (to stimulate cortical inhibition), and three will use paired-pulse stimulation with 11ms between pulses (to stimulate greater cortical excitation). Five different brain regions will be targeted: three individualized targets either derived anatomically (motor cortex) or based on the individual's resting-state functional connectivity (dorsolateral prefrontal cortex and angular gryus) and two regions that are based on the literature (dorsolateral prefrontal cortex and angular gryus).
- Conditions
- Healthy
- Being tested
- Concurrent transcranial magnetic stimulation and electroencephalogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent transcranial magnetic stimulation and electroencephalogramDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Device: Concurrent transcranial magnetic stimulation and electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Session 1 and session 2 with one week between sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start2 Dec 2022
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design. Each participant will undergo the same TMS/EEG procedures twice with one week in between sessions.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fred Barrett, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665634
- Sponsor's protocol ID
- IRB00233571
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Stimulation and Electroencephalography Pilot Study
- ClinicalTrials.gov ID
- NCT05665634
- Acronym / sponsor ID
- IRB00233571
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- This study will investigate whether the test-retest reliability of TEPs differ across TMS protocols.
- This study will investigate whether the test-retest reliability of TEPs differ between individualized and non-individualized targeting approaches.
Detailed description
Participants will first undergo functional magnetic resonance imaging (fMRI) scanning where structural and resting-state functional images will be obtained. In two separate sessions, participants will attend two concurrent TMS/EEG session with one week in between.
During the TMS/EEG sessions, an EEG cap will be placed on the participant's head and the resting motor threshold will be obtained to calibrate the TMS intensity required for the stimulation of target regions. Once setup procedures are complete, eleven total blocks of TMS with simultaneous EEG recording will take place. Among eleven blocks, five of will use single-pulse stimulation (to stimulate cortical excitation), three will use paired-pulse stimulation with 3ms between pulses (to stimulate cortical inhibition), and three will use paired-pulse stimulation with 11ms between pulses (to stimulate greater cortical excitation). Five different brain regions will be targeted: three individualized targets either derived anatomically (motor cortex) or based on the individual's resting-state functional connectivity (dorsolateral prefrontal cortex and angular gryus) and two regions that are based on the literature (dorsolateral prefrontal cortex and angular gryus).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject design. Each participant will undergo the same TMS/EEG procedures twice with one week in between sessions.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Concurrent transcranial magnetic stimulation and electroencephalogram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent transcranial magnetic stimulation and electroencephalogramSingle 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. | Device | All participants |
Primary outcome
Comparison of interclass correlation coefficients (ICC) of TMS Evoked Potential amplitudes, as measured by EEG, between single and paired-pulse TMS protocols
Time frame: Session 1 and session 2 with one week between sessions
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.
Comparison of interclass correlation coefficients (ICC) of TMS Evoked Potential amplitudes, as measured by EEG, between individualized and non-individualized targeting approaches
Time frame: Session 1 and session 2 with one week between sessions
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Barrett principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent transcranial magnetic stimulation and electroencephalogram in people with Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of interclass correlation coefficients (ICC) of TMS Evoked Potential amplitudes, as measured by EEG, between single and paired-pulse TMS protocols (time frame: Session 1 and session 2 with one week between sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.