HealthyNCT06354686

Characterizing the Scalp Tolerability of TMS

A study testing TMS Tolerability in people with Healthy, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: TMS Tolerability
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2024to 20 Feb 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults ages 18 years and older.
Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study.
Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).

Who cannot join

Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches).
Contraindication for knee sensitivity and tolerability testing (e.g., current knee injury or ongoing complications from prior history of knee surgery), unless knee testing skipped at the investigators' discretion.
Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion.
Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
Dementia or other cognitive disorder making unable to engage in study.

Show all 17Show fewer

Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.).
Any medication or substance use that significantly impacts sensory and tolerability measures based on the investigators' review of dosing and effect (e.g., topical anesthetics, botulinum toxin injections, ketamine, NSAIDS, opioids, anticonvulsants used in pain management, etc.).
Current, planned, or suspected pregnancy.
Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.).
Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
The investigators will exclude the following individuals:
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida State University
Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: Characterizing the Scalp Tolerability of Transcranial Magnetic Stimulation by Location and Stimulation Parameters

Conditions: Healthy
Being tested: TMS Tolerability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TMS TolerabilityDevice
The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the feasibility of the knee as a surrogate location to safely trial TMS parameters.

Study groups in NCT06354686
Study group	Role	What they receive
Single Arm	Experimental	This will be a single arm study with measurements of scalp location and TMS stimulation parameters. Receives: Device: TMS Tolerability

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensory Threshold
Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session.
Measured: During one study session lasting approximately 3 hours.
Annoyance Threshold
Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which the tactile sensation was first perceived as annoying during the study session.
Measured: During one study session lasting approximately 3 hours.
Tolerability Threshold
Maximum stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), tolerated before the stimulation was rated as troublesome or miserable during the study session.
Measured: During one study session lasting approximately 3 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 202420 Feb 2026

First posted9 Apr 2024
Study start14 Jun 2024
Primary completion20 Feb 2026
Study completion20 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Florida State 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06354686
Sponsor's protocol ID: STUDY00004245
Status last verified: Aug 2026
First submitted: 31 Jul 2023
Last updated: 21 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing the Scalp Tolerability of Transcranial Magnetic Stimulation by Location and Stimulation Parameters
ClinicalTrials.gov ID: NCT06354686
Acronym / sponsor ID: STUDY00004245
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Study start: 14 Jun 2024 (actual)
Primary completion: 20 Feb 2026 (actual)
Study completion: 20 Feb 2026 (actual)
First posted: 9 Apr 2024 (actual)
Results: Posted 27 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Device: TMS TolerabilityThis will be a single arm study with measurements of scalp location and TMS stimulation parameters.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults ages 18 years and older.
Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study.
Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).

Key exclusion criteria (17 listed)

Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches).
Contraindication for knee sensitivity and tolerability testing (e.g., current knee injury or ongoing complications from prior history of knee surgery), unless knee testing skipped at the investigators' discretion.
Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion.
Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment

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
TMS TolerabilityThe primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the feasibility of the knee as a surrogate location to safely trial TMS parameters.	Device	Single Arm

Primary outcome

Sensory Threshold
Time frame: During one study session lasting approximately 3 hours.
Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session.
Annoyance Threshold
Time frame: During one study session lasting approximately 3 hours.
Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which the tactile sensation was first perceived as annoying during the study session.
Tolerability Threshold
Time frame: During one study session lasting approximately 3 hours.
Maximum stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), tolerated before the stimulation was rated as troublesome or miserable during the study session.

Results and safety

Results posted to the registry on 27 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	20	18

Primary outcome: Sensory Threshold

Time frame: During one study session lasting approximately 3 hours.. Mean (Standard Deviation). Unit: percentage of sMT

Measure	Single Arm n = 18
Value	40.2 (9.4)

Primary outcome: Annoyance Threshold

Time frame: During one study session lasting approximately 3 hours.. Mean (Standard Deviation). Unit: percentage of sMT

Measure	Single Arm n = 18
Value	87.6 (29.1)

Primary outcome: Tolerability Threshold

Time frame: During one study session lasting approximately 3 hours.. Mean (Standard Deviation). Unit: percentage of sMT

Measure	Single Arm n = 18
Value	111.5 (28.5)

Adverse events

Time frame: During one study session lasting approximately 3 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Limitations and caveats (from the sponsor): Tolerability thresholds may have been underestimated because stimulation was capped at 120% of each participant's individual motor threshold for safety. Some trials were stopped at this safety limit before the participant reported reaching the tolerability threshold.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TMS Tolerability in people with Healthy, run by Florida State 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 3 inclusion and 17 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 21 Sep 2026. 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?

Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sensory Threshold (time frame: During one study session lasting approximately 3 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06354686.

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 21 Sep 2026.