Characterizing the Scalp Tolerability of TMS

NCT06354686 | Completed Results FDA Device

• 1 other identifier: STUDY00004245
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  During one study session lasting approximately 3 hours.

Study Arms (1)

Single Arm

EXPERIMENTAL

This will be a single arm study with measurements of scalp location and TMS stimulation parameters.

Device: TMS Tolerability

Interventions

TMS Tolerability DEVICE

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.

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Kevin Johnson
• Organization: Florida State University

fsun@med.fsu.edu

850-644-2824

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Faculty

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: April 9, 2024
• Study Start: June 14, 2024
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: September 21, 2026
• Results First Posted: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)